Diabetic Peripheral Neuropathic Pain
Conditions
Keywords
RTA 901
Brief summary
This is a 2-part, randomized, placebo-controlled, double-blind, Phase 2 study to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of RTA 901 in qualified participants with Diabetic Peripheral Neuropathic Pain (DPNP). Each study part will be randomized into 3 treatment arms; 2 different doses of RTA 901 and RTA 901-maching placebo. The doses of RTA 901 in Part 2 will be selected based on the Exposure-Response (E-R) analyses of data from Part 1. The duration of each part of the study will be approximately 20 weeks, including a Screening period of up to 2 weeks, a Run-in-period of 2 weeks, a Treatment period of 12 weeks, and a Follow-up period of 4 weeks. All participants in Part 1 and Part 2 of the study will follow the same visit and assessment schedule. Eligibility will be assessed during the Screening and Run-in-periods.
Detailed description
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
Interventions
DRUGRTA 901
Administered as specified in the treatment arm.
DRUGRTA 901-Matching Placebo
Administered as specified in the treatment arm.
Sponsors
Reata, a wholly owned subsidiary of Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Run-in Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) at least 1 year prior to Screening * Clinical diagnosis of DPNP defined as symptomatic distal symmetric polyneuropathy (secondary to diabetes) in the lower extremities, which may include symptoms of pain that is burning, lancinating, tingling, or shooting (electric shock-like). Pain in the lower extremities may occur with paresthesia or dysesthesia (unpleasant sensations of burning). Neuropathic pain may be accompanied by an exaggerated response to painful stimuli (hyperalgesia) and pain evoked by light touch or contact, eg, with socks, shoes, and bedclothes (allodynia); * NPRS pain intensity score ≥ 4 on an 11-point scale at Screening * A score ≥ 2.5 on the Michigan Neuropathy Screening Instrument (MNSI) Part B Run-in
Exclusion criteria
* Has neuropathy from a cause other than T1DM or T2DM * Has a condition other than DPNP that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression); * Diabetic foot ulceration or infection within 90 days prior to Screening * Prior participation in a study with RTA 901; NOTE: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Abnormality in Body Weight | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Weight decrease was characterized by a decrease of ≥7% from baseline and weight increase was characterized by an increase of ≥7% from baseline. |
| Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Vital sign parameters included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \< 36.0 and \> 38.0 degrees Celsius (c), pulse rate \< 60 and \> 100 beats per minute (bpm), systolic blood pressure \< 90, \> 140 and \> 160 millimeters of mercury (mmHg), diastolic blood pressure \< 50, \> 90 and \> 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate \< 12 and \> 20 breaths per minute. The categories with at least one participant with clinically significant vital sign abnormalities are reported. |
| Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG) | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Clinical significance of abnormalities in ECG was determined based on the investigator's discretion. |
| Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Hematology parameters included hematocrit, hemoglobin, erythrocytes, leukocytes, neutrophils, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin concentration. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported. |
| Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, choriogonadotropin beta, follicle stimulating hormone (FSH), estimated glomerular filtration rate (eGFR), ferritin, creatine kinase, blood urea nitrogen, creatinine, bilirubin(total and direct), alkaline phosphatase, amylase, lipase, sodium, potassium, calcium, phosphorus, uric acid, total protein, glucose, albumin, lactate dehydrogenase, magnesium, chloride, bicarbonate, and gamma-glutamyl transferase. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported. |
| Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Urinalysis included assessments of bacteria, Bilirubin, Calcium Oxalate Crystals, Choriogonadotropin Beta, Color, Erythrocytes, Glucose, Granular Casts, Hyaline Casts, Ketones, Leukocyte Esterase, Leukocytes, Nitrite, Occult Blood, Protein, red blood cells (RBC) Casts, Renal Epithelial Cells, Specific Gravity, Specimen Appearance, Squamous Epithelial Cells, Transitional Epithelial Cells, Triple Phosphate Crystals, Uric Acid Crystals, white blood cells (WBC) Casts and pH. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported. |
| Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Coagulation included assessments of prothrombin. The parameter was flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. |
| Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12 | Baseline, Week 12 | The NPRS of pain intensity is an 11-point numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participants were asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. The weekly average score of NPRS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. Negative change from baseline indicates decreased pain intensity. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | An adverse event (AE) was any unfavorable and unintended sign (including any CS abnormal laboratory test result), symptom, or disease temporally associated with use of the study drug, whether or not it is considered to be study drug related. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AEs that presented, or worsened in intensity or frequency, following the initiation of study treatment were categorized as TEAEs. |
| Number of Participants With Clinically Significant Abnormalities in Physical Examinations | From the first dose of study drug up to end of follow-up period (up to 16 weeks) | Clinically significant abnormalities in physical examinations were based on investigator discretion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved at Least a >=50% Decrease From Baseline in the Average NPRS Score at Week 12 | Baseline, Week 12 | Responder is defined as participants with at least \>=50% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. |
| Number of Participants Using Rescue Medications During the Treatment Period | Up to Week 12 | Rescue medication for diabetic peripheral neuropathic pain (DPNP) is in addition to standard of care medication (gabapentin, pregabalin or duloxetine) for DPNP. Rescue medication is intended to treat temporary elevations in a participant's DPNP and is intended to be used occasionally and not meant to be used for prolonged periods of time. |
| Amount of Rescue Medications Used During the Treatment Period | Up to Week 12 | The amount of rescue medication used per day during the 12-week treatment period was calculated as the total dosage recorded divided by total days of study drug exposure during the treatment period. |
| Time to First Occurrence of Rescue Medication Use | Up to Week 12 | Time to first occurrence of rescue medication use was defined as the time from first randomized dose to the first date of rescue medication use recorded in e-diary during the 12-week treatment period. If a participant withdraws from the study prior to week 12 and the participant did not take any rescue medication, then the participant will be censored on the last day in the study. |
| Change From Baseline in the Weekly Average of Daily Sleep Interference Scale (DSIS) Score at Week 12 | Baseline, Week 12 | DSIS is a participant reported outcome that was developed to quantify sleep interference due to pain. The DSIS was completed daily by participants upon waking, preferably in the morning, to accurately capture variability in sleep interference due to pain, thus minimizing recall bias. Using the e-diary, participants assessed how neuropathic pain has interfered with their sleep during the past 24 hours. This score ranges from 0 to 10; 0 representing no interference with sleep to 10 representing complete inability to sleep, lower score indicating less pain interference during sleep. The weekly average score of DSIS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. A negative change from baseline indicates decreased interference in sleep due to pain. |
| Number of Participants Who Achieved at Least a >=30% Decrease From Baseline in the Average NPRS Score at Week 12 | Baseline, Week 12 | Responders is defined as participants with at least \>=30% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12 and were analysed using a logistic regression. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. Lower scores indicate less pain. |
Countries
United States
Participant flow
Recruitment details
Participants took part at multiple investigative sites from 28 July 2023 to 15 November 2024.
Pre-assignment details
This study was to be conducted in 2 parts: Part 1 to investigate the efficacy and safety of 10 milligrams (mg) and 80 mg doses of RTA 901 and Part 2 to investigate doses of RTA 901 between 1 mg and 80 mg once daily (QD) based on the exposure-response (E-R) analysis for efficacy in Part 1. The study was terminated after Part 1 was completed and did not proceed to Part 2. No participants were enrolled in Part 2.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: RTA 901 Matching Placebo + SOC Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received a dose of RTA 901-matching placebo, QD, orally for 12-weeks during double blind treatment period. | 68 |
| Part 1: RTA 901 10 mg + SOC Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 10 mg, QD, orally for 12-weeks during double blind treatment period. | 69 |
| Part 1: RTA 901 80 mg + SOC Participants received a single blind placebo, capsule, QD, orally, during the 2-week Run-in Period along with any one prescribed SOC pain medication (duloxetine, pregabalin, or gabapentin). Following randomization, the participants received RTA 901, 80 mg, QD, orally for 12-weeks during treatment period. | 69 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 1 |
| Overall Study | Failure to Meet Randomization Criteria | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Non-Compliance With Study Drug | 0 | 1 | 0 |
| Overall Study | Protocol Deviation | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 4 |
Baseline characteristics
| Characteristic | Part 1: RTA 901 Matching Placebo + SOC | Part 1: RTA 901 10 mg + SOC | Part 1: RTA 901 80 mg + SOC | Total |
|---|---|---|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 7.13 | 63.1 years STANDARD_DEVIATION 9.97 | 64.6 years STANDARD_DEVIATION 7.57 | 64.3 years STANDARD_DEVIATION 8.33 |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 31 Participants | 34 Participants | 33 Participants | 98 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 37 Participants | 35 Participants | 36 Participants | 108 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African America | 14 Participants | 16 Participants | 15 Participants | 45 Participants |
| Race/Ethnicity, Customized Race Multiple | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 50 Participants | 49 Participants | 53 Participants | 152 Participants |
| Sex: Female, Male Female | 37 Participants | 33 Participants | 36 Participants | 106 Participants |
| Sex: Female, Male Male | 31 Participants | 36 Participants | 33 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 14 / 68 | 13 / 69 | 12 / 69 |
| serious Total, serious adverse events | 4 / 68 | 5 / 69 | 1 / 69 |
Outcome results
Primary
Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12
The NPRS of pain intensity is an 11-point numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participants were asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. The weekly average score of NPRS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. Negative change from baseline indicates decreased pain intensity.
Time frame: Baseline, Week 12
Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12 | -1.71 score on a scale | Standard Error 0.249 |
| Part 1: RTA 901 10 mg + SOC | Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12 | -1.49 score on a scale | Standard Error 0.248 |
| Part 1: RTA 901 80 mg + SOC | Change From Baseline in Weekly Average Pain Intensity Assessed by the Numeric Pain Rating Scale (NPRS) at Week 12 | -1.79 score on a scale | Standard Error 0.248 |
p-value: <0.522495% CI: [-0.468, 0.918]MMRM
p-value: <0.822395% CI: [-0.772, 0.614]MMRM
Primary
Number of Participants With Clinically Significant Abnormalities in Physical Examinations
Clinically significant abnormalities in physical examinations were based on investigator discretion.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Clinically Significant Abnormalities in Physical Examinations | 0 Participants |
Primary
Number of Participants With Clinically Significant Abnormality in Body Weight
Weight decrease was characterized by a decrease of ≥7% from baseline and weight increase was characterized by an increase of ≥7% from baseline.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Clinically Significant Abnormality in Body Weight | Weight 7% or more increase from baseline | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Clinically Significant Abnormality in Body Weight | Weight 7% or more decrease from baseline | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Clinically Significant Abnormality in Body Weight | Weight 7% or more increase from baseline | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Clinically Significant Abnormality in Body Weight | Weight 7% or more decrease from baseline | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Clinically Significant Abnormality in Body Weight | Weight 7% or more increase from baseline | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Clinically Significant Abnormality in Body Weight | Weight 7% or more decrease from baseline | 1 Participants |
Primary
Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters
Vital sign parameters included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \< 36.0 and \> 38.0 degrees Celsius (c), pulse rate \< 60 and \> 100 beats per minute (bpm), systolic blood pressure \< 90, \> 140 and \> 160 millimeters of mercury (mmHg), diastolic blood pressure \< 50, \> 90 and \> 100 mmHg, weight (7% or more increase from baseline, 7% or more decrease from baseline) and respiratory rate \< 12 and \> 20 breaths per minute. The categories with at least one participant with clinically significant vital sign abnormalities are reported.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Pulse Rate >100 bpm | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Temperature <36 degrees C | 15 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Temperature >38 degrees C | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Pulse Rate <60 bpm | 18 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure <90 mmHg | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure >140 mmHg | 24 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure >160 mmHg | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure <50 mmHg | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure >90 mmHg | 6 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure >100 mmHg | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Weight 7% or more increase from baseline | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Weight 7% or more decrease from baseline | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Respiratory Rate <12 breaths/min | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Respiratory Rate >20 breaths/min | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure <90 mmHg | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure >140 mmHg | 28 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Weight 7% or more decrease from baseline | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure >160 mmHg | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure <50 mmHg | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Respiratory Rate >20 breaths/min | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure >90 mmHg | 9 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Respiratory Rate <12 breaths/min | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Weight 7% or more increase from baseline | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure >100 mmHg | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Temperature <36 degrees C | 17 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Temperature >38 degrees C | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Pulse Rate <60 bpm | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Pulse Rate >100 bpm | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Respiratory Rate <12 breaths/min | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure <90 mmHg | 3 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Respiratory Rate >20 breaths/min | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Pulse Rate >100 bpm | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure >140 mmHg | 22 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Pulse Rate <60 bpm | 11 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Temperature >38 degrees C | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Systolic Blood Pressure >160 mmHg | 3 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Weight 7% or more decrease from baseline | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Temperature <36 degrees C | 16 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure <50 mmHg | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure >100 mmHg | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Weight 7% or more increase from baseline | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Potential Clinically Significant Abnormalities in Vital Sign Parameters | Diastolic Blood Pressure >90 mmHg | 6 Participants |
Primary
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters)
Parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, choriogonadotropin beta, follicle stimulating hormone (FSH), estimated glomerular filtration rate (eGFR), ferritin, creatine kinase, blood urea nitrogen, creatinine, bilirubin(total and direct), alkaline phosphatase, amylase, lipase, sodium, potassium, calcium, phosphorus, uric acid, total protein, glucose, albumin, lactate dehydrogenase, magnesium, chloride, bicarbonate, and gamma-glutamyl transferase. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lactate Dehydrogenase Shift to High | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Cholesterol Shift to High | 9 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Albumin Shift to Low | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lactate Dehydrogenase Shift to Low | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatine Kinase Shift to Low | 6 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Sodium Shift to High | 8 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | LDL Cholesterol Shift to High | 11 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatine Kinase Shift to High | 17 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Amylase Shift to High | 12 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | LDL Cholesterol Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatinine Shift to Low | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urea Nitrogen Shift to High | 14 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | HDL Cholesterol Shift to High | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatinine Shift to High | 16 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Sodium Shift to Low | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | HDL Cholesterol Shift to Low | 8 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Direct Bilirubin Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | AST Shift to Low | 9 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Glucose Shift to High | 14 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Direct Bilirubin Shift to High | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urate Shift to High | 11 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Glucose Shift to Low | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Ferritin Shift to Low | 9 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Protein Shift to High | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | eGFR Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Ferritin Shift to High | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | AST Shift to High | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | eGFR Shift to Low | 14 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Gamma Glutamyl Transferase Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Albumin Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Gamma Glutamyl Transferase Shift to High | 8 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Protein Shift to Low | 9 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bicarbonate Shift to Low | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | ALT Shift to High | 13 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Potassium Shift to High | 19 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bicarbonate Shift to High | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urate Shift to Low | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Potassium Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bilirubin Shift to Low | 9 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Alkaline Phosphatase Shift to Low | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Phosphate Shift to High | 14 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bilirubin Shift to High | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | ALT Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Phosphate Shift to Low | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Calcium Shift to Low | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Triglycerides Shift to High | 17 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Magnesium Shift to High | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Calcium Shift to High | 6 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Alkaline Phosphatase Shift to High | 12 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Magnesium Shift to Low | 4 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Chloride Shift to Low | 4 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urea Nitrogen Shift to Low | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lipase Shift to High | 17 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Chloride Shift to High | 6 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Triglycerides Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lipase Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Cholesterol Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Amylase Shift to Low | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Sodium Shift to Low | 8 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urate Shift to Low | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | ALT Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | ALT Shift to High | 17 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Albumin Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Albumin Shift to High | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Alkaline Phosphatase Shift to Low | 3 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Alkaline Phosphatase Shift to High | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Amylase Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Amylase Shift to High | 11 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | AST Shift to Low | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | AST Shift to High | 14 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bicarbonate Shift to Low | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bicarbonate Shift to High | 9 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bilirubin Shift to Low | 5 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bilirubin Shift to High | 3 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Calcium Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Calcium Shift to High | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Chloride Shift to Low | 8 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Chloride Shift to High | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Cholesterol Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Cholesterol Shift to High | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatine Kinase Shift to Low | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatine Kinase Shift to High | 23 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatinine Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatinine Shift to High | 11 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Direct Bilirubin Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Direct Bilirubin Shift to High | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Ferritin Shift to Low | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Ferritin Shift to High | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Gamma Glutamyl Transferase Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Gamma Glutamyl Transferase Shift to High | 8 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | eGFR Shift to Low | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | eGFR Shift to High | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Glucose Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Glucose Shift to High | 14 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | HDL Cholesterol Shift to Low | 11 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | HDL Cholesterol Shift to High | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | LDL Cholesterol Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | LDL Cholesterol Shift to High | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lactate Dehydrogenase Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lactate Dehydrogenase Shift to High | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lipase Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lipase Shift to High | 22 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Magnesium Shift to Low | 5 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Magnesium Shift to High | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Phosphate Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Phosphate Shift to High | 21 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Potassium Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Potassium Shift to High | 22 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Protein Shift to Low | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Protein Shift to High | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Sodium Shift to High | 8 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Triglycerides Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Triglycerides Shift to High | 16 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urate Shift to High | 9 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urea Nitrogen Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urea Nitrogen Shift to High | 23 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Cholesterol Shift to High | 11 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Sodium Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lactate Dehydrogenase Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Cholesterol Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Alkaline Phosphatase Shift to High | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lactate Dehydrogenase Shift to High | 11 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Chloride Shift to High | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urea Nitrogen Shift to High | 15 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lipase Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Chloride Shift to Low | 6 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Triglycerides Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Lipase Shift to High | 23 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Calcium Shift to High | 8 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Alkaline Phosphatase Shift to Low | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Magnesium Shift to Low | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Calcium Shift to Low | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urea Nitrogen Shift to Low | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Magnesium Shift to High | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bilirubin Shift to High | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Triglycerides Shift to High | 21 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Phosphate Shift to Low | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bilirubin Shift to Low | 10 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Albumin Shift to High | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bicarbonate Shift to High | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urate Shift to Low | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Potassium Shift to Low | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Bicarbonate Shift to Low | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Albumin Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Potassium Shift to High | 20 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | AST Shift to High | 6 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | ALT Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Gamma Glutamyl Transferase Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Protein Shift to Low | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Gamma Glutamyl Transferase Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Ferritin Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | AST Shift to Low | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | eGFR Shift to Low | 12 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Ferritin Shift to Low | 10 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Urate Shift to High | 11 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | eGFR Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Direct Bilirubin Shift to High | 6 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Protein Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Glucose Shift to Low | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Direct Bilirubin Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Amylase Shift to High | 9 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Glucose Shift to High | 16 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatinine Shift to High | 15 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Phosphate Shift to High | 16 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | HDL Cholesterol Shift to Low | 12 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatinine Shift to Low | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Sodium Shift to Low | 3 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | HDL Cholesterol Shift to High | 3 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatine Kinase Shift to High | 18 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Amylase Shift to Low | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | LDL Cholesterol Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | Creatine Kinase Shift to Low | 8 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | ALT Shift to High | 13 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Blood Chemistry Parameters) | LDL Cholesterol Shift to High | 11 Participants |
Primary
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters)
Coagulation included assessments of prothrombin. The parameter was flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin International Normalized Ratio Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin International Normalized Ratio Shift to High | 13 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin Time Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin Time Shift to High | 14 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin Time Shift to High | 21 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin International Normalized Ratio Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin Time Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin International Normalized Ratio Shift to High | 20 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin Time Shift to High | 19 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin International Normalized Ratio Shift to High | 16 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin Time Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Coagulation Parameters) | Prothrombin International Normalized Ratio Shift to Low | 0 Participants |
Primary
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters)
Hematology parameters included hematocrit, hemoglobin, erythrocytes, leukocytes, neutrophils, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin concentration. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Shift to Low | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils/Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes Shift to High | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Shift to High | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Platelets Shift to High | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes Shift to Low | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hematocrit Shift to Low | 14 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils/Leukocytes Shift to Low | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Leukocytes Shift to High | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hematocrit Shift to High | 6 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils/Leukocytes Shift to High | 9 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Leukocytes Shift to Low | 4 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin Shift to Low | 11 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils Shift to High | 10 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin A1C/Hemoglobin Shift to High | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin Shift to High | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to Low | 19 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin A1C/Hemoglobin Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes/Leukocytes Shift to Low | 15 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Platelets Shift to Low | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils Shift to Low | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes/Leukocytes Shift to High | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Shift to Low | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Basophils/Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes/Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils Shift to High | 6 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes Shift to High | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Volume Shift to Low | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Basophils/Leukocytes Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Volume Shift to High | 1 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils/Leukocytes Shift to High | 15 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes/Leukocytes Shift to High | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils Shift to High | 9 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils/Leukocytes Shift to High | 11 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Basophils/Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Basophils/Leukocytes Shift to High | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils Shift to High | 5 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils/Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to Low | 19 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to High | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Shift to High | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Volume Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Volume Shift to High | 3 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Shift to Low | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Shift to High | 8 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hematocrit Shift to Low | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hematocrit Shift to High | 6 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin Shift to Low | 8 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin Shift to High | 3 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin A1C/Hemoglobin Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin A1C/Hemoglobin Shift to High | 3 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Leukocytes Shift to Low | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Leukocytes Shift to High | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes Shift to High | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes/Leukocytes Shift to Low | 23 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes/Leukocytes Shift to High | 5 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes Shift to High | 8 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes/Leukocytes Shift to Low | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes/Leukocytes Shift to High | 5 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils Shift to Low | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils/Leukocytes Shift to Low | 4 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils/Leukocytes Shift to High | 21 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Platelets Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Platelets Shift to High | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Platelets Shift to Low | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes/Leukocytes Shift to Low | 17 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Volume Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils/Leukocytes Shift to Low | 3 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes/Leukocytes Shift to High | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Volume Shift to Low | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils Shift to High | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes Shift to High | 10 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Shift to Low | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils/Leukocytes Shift to High | 15 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes/Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Basophils/Leukocytes Shift to High | 3 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Monocytes/Leukocytes Shift to High | 9 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Mean Corpuscular Hemoglobin Concentration Shift to Low | 23 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin Shift to High | 2 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Platelets Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin A1C/Hemoglobin Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin Shift to Low | 13 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils Shift to Low | 3 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hemoglobin A1C/Hemoglobin Shift to High | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hematocrit Shift to High | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils/Leukocytes Shift to High | 13 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Leukocytes Shift to Low | 11 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Hematocrit Shift to Low | 12 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Basophils/Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Leukocytes Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Shift to High | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Neutrophils Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Lymphocytes Shift to Low | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Erythrocytes Shift to Low | 10 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Hematology Parameters) | Eosinophils/Leukocytes Shift to Low | 0 Participants |
Primary
Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis)
Urinalysis included assessments of bacteria, Bilirubin, Calcium Oxalate Crystals, Choriogonadotropin Beta, Color, Erythrocytes, Glucose, Granular Casts, Hyaline Casts, Ketones, Leukocyte Esterase, Leukocytes, Nitrite, Occult Blood, Protein, red blood cells (RBC) Casts, Renal Epithelial Cells, Specific Gravity, Specimen Appearance, Squamous Epithelial Cells, Transitional Epithelial Cells, Triple Phosphate Crystals, Uric Acid Crystals, white blood cells (WBC) Casts and pH. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants available for this outcome measure analysis. 'Number analyzed' signifies the number of participants with data available for analysis at specified time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | WBC Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Granular Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Granular Casts Shift to High | 8 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Hyaline Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Hyaline Casts Shift to High | 6 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Ketones Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Ketones Shift to High | 11 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocyte Esterase Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocyte Esterase Shift to High | 18 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocytes Shift to High | 18 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Nitrite Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Nitrite Shift to High | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Occult Blood Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Occult Blood Shift to High | 15 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Protein Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Protein Shift to High | 23 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | RBC Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | RBC Casts Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Specific Gravity Shift to Low | 8 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Specific Gravity Shift to High | 24 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Transitional Epithelial Cells Shift to Low | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Transitional Epithelial Cells Shift to High | 3 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Uric Acid Crystals Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Uric Acid Crystals Shift to High | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | WBC Casts Shift to High | 2 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Waxy Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Waxy Casts Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Yeast Cells Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Yeast Cells Shift to High | 4 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | pH Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | pH Shift to High | 5 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Bilirubin Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Bilirubin Shift to High | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Calcium Oxalate Crystals Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Calcium Oxalate Crystals Shift to High | 12 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Erythrocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Erythrocytes Shift to High | 8 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Glucose Shift to Low | 0 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Glucose Shift to High | 19 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Erythrocytes Shift to High | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Granular Casts Shift to High | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | WBC Casts Shift to High | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Specific Gravity Shift to Low | 11 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Yeast Cells Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Glucose Shift to High | 15 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Protein Shift to High | 20 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Bilirubin Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Granular Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Specific Gravity Shift to High | 24 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Calcium Oxalate Crystals Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Occult Blood Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Waxy Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Hyaline Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | pH Shift to High | 7 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Transitional Epithelial Cells Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Hyaline Casts Shift to High | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | RBC Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Glucose Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Ketones Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Transitional Epithelial Cells Shift to High | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Waxy Casts Shift to High | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Ketones Shift to High | 9 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | pH Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Bilirubin Shift to High | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocyte Esterase Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Uric Acid Crystals Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Protein Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocyte Esterase Shift to High | 19 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | RBC Casts Shift to High | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Uric Acid Crystals Shift to High | 3 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Occult Blood Shift to High | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Calcium Oxalate Crystals Shift to High | 12 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocytes Shift to High | 14 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | WBC Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Yeast Cells Shift to High | 1 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Nitrite Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Erythrocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Nitrite Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Yeast Cells Shift to High | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Nitrite Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Glucose Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Occult Blood Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Occult Blood Shift to High | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | pH Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Protein Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Protein Shift to High | 18 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | RBC Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | pH Shift to High | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | RBC Casts Shift to High | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Erythrocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Specific Gravity Shift to Low | 12 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Specific Gravity Shift to High | 20 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Bilirubin Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Transitional Epithelial Cells Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Transitional Epithelial Cells Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Uric Acid Crystals Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Bilirubin Shift to High | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Uric Acid Crystals Shift to High | 4 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | WBC Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Waxy Casts Shift to High | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Glucose Shift to High | 18 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | WBC Casts Shift to High | 1 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Granular Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Granular Casts Shift to High | 9 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Hyaline Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Waxy Casts Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Hyaline Casts Shift to High | 9 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Calcium Oxalate Crystals Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Ketones Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Ketones Shift to High | 7 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Erythrocytes Shift to High | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocyte Esterase Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Yeast Cells Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocyte Esterase Shift to High | 23 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Calcium Oxalate Crystals Shift to High | 11 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocytes Shift to Low | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Leukocytes Shift to High | 13 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinical Laboratory Measurement (Urinalysis) | Nitrite Shift to Low | 0 Participants |
Primary
Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG)
Clinical significance of abnormalities in ECG was determined based on the investigator's discretion.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG) | 2 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG) | 0 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Shift From Baseline in Clinically Significant Abnormalities in Electrocardiogram (ECG) | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period
An adverse event (AE) was any unfavorable and unintended sign (including any CS abnormal laboratory test result), symptom, or disease temporally associated with use of the study drug, whether or not it is considered to be study drug related. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AEs that presented, or worsened in intensity or frequency, following the initiation of study treatment were categorized as TEAEs.
Time frame: From the first dose of study drug up to end of follow-up period (up to 16 weeks)
Population: The safety analysis set includes all randomized participants who receive at least 1 dose of randomized study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period | TEAEs | 39 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period | SAEs | 4 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period | TEAEs | 43 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period | SAEs | 5 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period | TEAEs | 35 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) During and Following the Treatment Period | SAEs | 1 Participants |
Secondary
Amount of Rescue Medications Used During the Treatment Period
The amount of rescue medication used per day during the 12-week treatment period was calculated as the total dosage recorded divided by total days of study drug exposure during the treatment period.
Time frame: Up to Week 12
Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Amount of Rescue Medications Used During the Treatment Period | NSAIDs | 18.40 milligrams (mg) per day | Standard Deviation 64.4 |
| Part 1: RTA 901 Matching Placebo + SOC | Amount of Rescue Medications Used During the Treatment Period | Acetaminophen | 55.50 milligrams (mg) per day | Standard Deviation 146.374 |
| Part 1: RTA 901 10 mg + SOC | Amount of Rescue Medications Used During the Treatment Period | NSAIDs | 14.72 milligrams (mg) per day | Standard Deviation 51.06 |
| Part 1: RTA 901 10 mg + SOC | Amount of Rescue Medications Used During the Treatment Period | Acetaminophen | 91.31 milligrams (mg) per day | Standard Deviation 308.725 |
| Part 1: RTA 901 80 mg + SOC | Amount of Rescue Medications Used During the Treatment Period | NSAIDs | 48.15 milligrams (mg) per day | Standard Deviation 166.396 |
| Part 1: RTA 901 80 mg + SOC | Amount of Rescue Medications Used During the Treatment Period | Acetaminophen | 101.09 milligrams (mg) per day | Standard Deviation 268.488 |
Secondary
Change From Baseline in the Weekly Average of Daily Sleep Interference Scale (DSIS) Score at Week 12
DSIS is a participant reported outcome that was developed to quantify sleep interference due to pain. The DSIS was completed daily by participants upon waking, preferably in the morning, to accurately capture variability in sleep interference due to pain, thus minimizing recall bias. Using the e-diary, participants assessed how neuropathic pain has interfered with their sleep during the past 24 hours. This score ranges from 0 to 10; 0 representing no interference with sleep to 10 representing complete inability to sleep, lower score indicating less pain interference during sleep. The weekly average score of DSIS was defined as the sum of non-missing daily scores divided by the number of days with non-missing scores for that week. A negative change from baseline indicates decreased interference in sleep due to pain.
Time frame: Baseline, Week 12
Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants evaluable for this outcome measure analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Change From Baseline in the Weekly Average of Daily Sleep Interference Scale (DSIS) Score at Week 12 | -1.52 score on a scale | Standard Deviation 2.035 |
| Part 1: RTA 901 10 mg + SOC | Change From Baseline in the Weekly Average of Daily Sleep Interference Scale (DSIS) Score at Week 12 | -1.41 score on a scale | Standard Deviation 1.749 |
| Part 1: RTA 901 80 mg + SOC | Change From Baseline in the Weekly Average of Daily Sleep Interference Scale (DSIS) Score at Week 12 | -2.00 score on a scale | Standard Deviation 2.249 |
Secondary
Number of Participants Using Rescue Medications During the Treatment Period
Rescue medication for diabetic peripheral neuropathic pain (DPNP) is in addition to standard of care medication (gabapentin, pregabalin or duloxetine) for DPNP. Rescue medication is intended to treat temporary elevations in a participant's DPNP and is intended to be used occasionally and not meant to be used for prolonged periods of time.
Time frame: Up to Week 12
Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 3 | 20 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 7 | 10 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 1 | 20 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 2 | 19 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 4 | 18 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 5 | 15 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 6 | 14 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 8 | 14 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 9 | 11 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 10 | 7 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 11 | 9 Participants |
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 12 | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 10 | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 3 | 15 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 5 | 11 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 4 | 13 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 11 | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 7 | 14 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 12 | 13 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 9 | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 1 | 15 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 6 | 10 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 8 | 14 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 2 | 16 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 8 | 19 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 3 | 22 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 11 | 12 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 4 | 18 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 10 | 15 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 6 | 16 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 7 | 16 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 12 | 14 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 2 | 19 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 5 | 18 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 1 | 22 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Using Rescue Medications During the Treatment Period | Week 9 | 13 Participants |
Secondary
Number of Participants Who Achieved at Least a >=30% Decrease From Baseline in the Average NPRS Score at Week 12
Responders is defined as participants with at least \>=30% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12 and were analysed using a logistic regression. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours. Lower scores indicate less pain.
Time frame: Baseline, Week 12
Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Who Achieved at Least a >=30% Decrease From Baseline in the Average NPRS Score at Week 12 | 26 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Who Achieved at Least a >=30% Decrease From Baseline in the Average NPRS Score at Week 12 | 22 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Who Achieved at Least a >=30% Decrease From Baseline in the Average NPRS Score at Week 12 | 28 Participants |
Secondary
Number of Participants Who Achieved at Least a >=50% Decrease From Baseline in the Average NPRS Score at Week 12
Responder is defined as participants with at least \>=50% reduction in neuropathic pain from baseline in the NPRS average neuropathic pain intensity at Week 12. The NPRS of pain intensity is a numeric scale, ranging from 0 (representing no pain at all) to 10 (representing the worst pain imaginable). The participant was asked to select a whole number (0 to 10) that best indicates the intensity of his/her neuropathic pain in the past 24 hours.
Time frame: Baseline, Week 12
Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Number of Participants Who Achieved at Least a >=50% Decrease From Baseline in the Average NPRS Score at Week 12 | 17 Participants |
| Part 1: RTA 901 10 mg + SOC | Number of Participants Who Achieved at Least a >=50% Decrease From Baseline in the Average NPRS Score at Week 12 | 12 Participants |
| Part 1: RTA 901 80 mg + SOC | Number of Participants Who Achieved at Least a >=50% Decrease From Baseline in the Average NPRS Score at Week 12 | 18 Participants |
Secondary
Time to First Occurrence of Rescue Medication Use
Time to first occurrence of rescue medication use was defined as the time from first randomized dose to the first date of rescue medication use recorded in e-diary during the 12-week treatment period. If a participant withdraws from the study prior to week 12 and the participant did not take any rescue medication, then the participant will be censored on the last day in the study.
Time frame: Up to Week 12
Population: The ITT analysis set was defined as all randomized participants who received at least 1 dose of randomized study drug. Here, 'overall number of participants analyzed' signifies the number of participants with first occurrence of rescue medication use.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part 1: RTA 901 Matching Placebo + SOC | Time to First Occurrence of Rescue Medication Use | NA days |
| Part 1: RTA 901 10 mg + SOC | Time to First Occurrence of Rescue Medication Use | NA days |
| Part 1: RTA 901 80 mg + SOC | Time to First Occurrence of Rescue Medication Use | NA days |