Healthy Male Adults Participants
Conditions
Brief summary
The purpose of this study is to characterize the safety and tolerability profile of TAK-792 when administered as a single oral dose in healthy Japanese and Caucasian male participants.
Detailed description
This study will be double-blind and placebo-controlled to avoid subjective bias in the assessment of safety and tolerability of TAK-792. Sentinel dosing will be used in the first cohort (cohort 1) to ensure adequate safety and tolerability evaluation prior to administering TAK-792 to the remainder of participants within the cohort. The dose escalation to the next cohort for Cohorts 2 to 6 will occur after full review of safety and tolerability of the current cohort, and available pharmacokinetic data up to 24 hours in the preceding cohorts. The planned dose levels are 30, 100, 250, 500, 750 and 1250 mg, to be administered in the morning after a fast of at least 10 hours.
Interventions
DRUGTAK-792 30 mg
TAK-792 30 mg was administered in the morning after a fast.
DRUGTAK-792 30 mg placebo
TAK-792 30 mg placebo was administered in the morning after a fast.
DRUGTAK-792 100 mg
TAK-792 100 mg was administered in the morning after a fast.
DRUGTAK-792 100 mg placebo
TAK-792 100 mg placebo was administered in the morning after a fast.
DRUGTAK-792 250 mg
TAK-792 250 mg was administered in the morning after a fast.
DRUGTAK-792 250 mg placebo
TAK-792 250 mg placebo was administered in the morning after a fast.
DRUGTAK-792 500 mg
TAK-792 500 mg was administered in the morning after a fast or after breakfast.
DRUGTAK-792 500 mg placebo
TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast.
DRUGTAK-792 750 mg
TAK-792 750 mg was administered in the morning after a fast.
DRUGTAK-792 750 mg placebo
TAK-792 750 mg placebo was administered in the morning after a fast.
DRUGTAK-792 1250 mg
TAK-792 1250 mg was administered in the morning after a fast.
DRUGTAK-792 1250 mg placebo
TAK-792 1250 mg placebo was administered in the morning after a fast.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. The participant is a healthy male of Japanese descent (born to Japanese parents and grandparents) or Caucasian descent (born to Caucasian parents and grandparents). 4. The participant is aged 20 to 45 years, inclusive, at the time of informed consent. 5. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 18.5 kilogram per square meter (kg/m\^2) and 25.0 kg/m\^2 for Japanese, BMI between 18.5 kg/m\^2 and 30.0 kg/m\^2 for Caucasian, inclusive at Screening and Day -1. 6. A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 12 weeks after last dose.
Exclusion criteria
. 1. The participant has received any investigational compound within 16 weeks (112 days) prior to the dose of study medication. 2. The participant is an immediate family member, study site employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 3. The participant has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results. 4. The participant has a positive urine drug result for drugs of abuse at Screening. 5. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 2 years prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. 6. Participant has taken any excluded medication, supplements, or food products listed in the Excluded Medications and Dietary Products table. 7. The participant intends to donate sperm during the course of this study or for 12 weeks thereafter. 8. Participant has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash. 9. Participant has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis frequent \[more than once per week\] occurrence of heartburn, or any surgical intervention \[eg, cholecystectomy\]). 10. Participant has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to Day 1. 11. Participant has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus (HIV) antibody/antigen, or serological reactions for syphilis at Screening. 12. Participant has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to Check-in Day -1. Cotinine test is positive at Screening. 13. The participant has poor peripheral venous access. 14. The participant has undergone whole blood collection of at least 200 milliliter (mL) within 4 weeks (28 days) or at least 400 mL within 12 weeks (84 days) prior to the start of study drug administration. 15. The participant has undergone whole blood collection of at least 800 mL in total within 52 weeks (364 days) prior to the start of study drug administration. 16. The participant has undergone blood component collection within 2 weeks (14 days) prior to the start of study drug administration. 17. Participant has a Screening abnormal (clinically significant) electrocardiogram (ECG). 18. Participant has abnormal Screening laboratory values that suggest a clinically significant underlying disease or participant with the following lab abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (\>)1.5 the upper limits of normal. 19. Participant who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | Baseline up to Day 8 | — |
| Number of Participants With TEAE Related to Vital Signs | Baseline up to Day 5 | Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute \[bpm\]). |
| Number of Participants With TEAE Related to Body Weight | Baseline up to Day 5 | — |
| Number of Participants With TEAE Related to Electrocardiograms (ECG) | Baseline up to Day 5 | — |
| Number of Participants With TEAEs Related to Laboratory Tests | Baseline up to Day 5 | Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased. |
| Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Baseline up to Day 5 | The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft. |
Secondary
| Measure | Time frame |
|---|---|
| Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose |
| AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose |
| AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose |
| AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day -1: pre-dose and Day 1 (2.5 hours post dose) |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in Japan from 27 May 2015 to 28 January 2016.
Pre-assignment details
Healthy Japanese participants received TAK-792 or placebo in Cohort 1a (30 milligram \[mg\]), Cohort 2a (100 mg), Cohort 3a (250 mg), Cohort 4a (500 mg), Cohort 5a (750 mg), and Cohort 6a (1250 mg). Healthy Caucasian participants received TAK-792 or placebo in Cohort 4b (500 mg), Cohort 5b (750 mg) and Cohort 6b (1250 mg).
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1a-6a: Placebo TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 12 |
| Cohort 1a: TAK-792 30 mg TAK-792 30 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 6 |
| Cohort 2a: TAK-792 100 mg TAK-792 100 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 6 |
| Cohort 3a: TAK-792 250 mg TAK-792 250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 6 |
| Cohort 4a: TAK-792 500 mg TAK-792 500 mg, tablets, orally, once in fasted state (4a-1) on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fed state (4a-2) on Day 1 of another 5-day treatment period. | 5 |
| Cohort 5a: TAK-792 750 mg TAK-792 750 mg, tablets, orally in fasted state (5a-1), once on Day 1 of 5-day treatment period, in Japanese participants. Participants also received same medication later in fasted state (5a-2) on Day 1 of another 5-day treatment period. | 6 |
| Cohort 6a: TAK-792 1250 mg TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Japanese participants. | 6 |
| Cohort 4b-6b: Placebo TAK-792 placebo-matching tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 6 |
| Cohort 4b: TAK-792 500 mg TAK-792 500 mg, tablets, orally, once in fasted state (4b-1) on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fed state (4b-2) on Day 1 of another 5-day treatment period. | 6 |
| Cohort 5b: TAK-792 750 mg TAK-792 750 mg, tablets, orally in fasted state (5b-1), once on Day 1 of 5-day treatment period, in Caucasian participants. Participants also received same medication later in fasted state (5b-2) on Day 1 of another 5-day treatment period. | 6 |
| Cohort 6b: TAK-792 1250 mg TAK-792 1250 mg, tablets, orally in fasted state, once on Day 1 of 5-day treatment period, in Caucasian participants. | 6 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Cohort 6b: TAK-792 1250 mg | Cohort 5b: TAK-792 750 mg | Cohort 4b: TAK-792 500 mg | Cohort 4b-6b: Placebo | Cohort 6a: TAK-792 1250 mg | Cohort 5a: TAK-792 750 mg | Cohort 4a: TAK-792 500 mg | Cohort 3a: TAK-792 250 mg | Cohort 2a: TAK-792 100 mg | Cohort 1a: TAK-792 30 mg | Cohort 1a-6a: Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants |
| Alcohol Classification Did not drink | 20 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants |
| Alcohol Classification Drank a few days per month | 46 Participants | 5 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 6 Participants |
| Alcohol Classification Drank a few days per week | 5 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Caffeine Classification Caffeine Consumption | 26 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 0 Participants | 4 Participants | 3 Participants | 3 Participants |
| Caffeine Classification No Caffeine Consumption | 45 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 2 Participants | 6 Participants | 2 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Caucasian | 24 participants | 6 participants | 6 participants | 6 participants | 6 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Japanese | 47 participants | 0 participants | 0 participants | 0 participants | 0 participants | 6 participants | 6 participants | 5 participants | 6 participants | 6 participants | 6 participants | 12 participants |
| Region of Enrollment Japan | 71 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 5 participants | 6 participants | 6 participants | 6 participants | 12 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 71 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants |
| Smoking Classification Ex-Smoker | 29 Participants | 4 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 6 Participants |
| Smoking Classification Never Smoked | 42 Participants | 2 Participants | 5 Participants | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 12 | 1 / 6 | 0 / 6 | 2 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 0 / 2 | 0 / 5 | 0 / 2 | 0 / 6 | 3 / 6 | 2 / 6 | 0 / 6 | 2 / 6 | 1 / 2 | 1 / 6 | 0 / 2 | 1 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 0 / 5 | 0 / 2 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 2 | 0 / 6 | 0 / 2 | 0 / 6 |
Outcome results
Primary
Number of Participants With TEAE Related to Body Weight
Time frame: Baseline up to Day 5
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1a-6a: Placebo | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAE Related to Body Weight | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAE Related to Body Weight | 0 Participants |
Primary
Number of Participants With TEAE Related to Electrocardiograms (ECG)
Time frame: Baseline up to Day 5
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1a-6a: Placebo | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAE Related to Electrocardiograms (ECG) | 0 Participants |
Primary
Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)
The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft.
Time frame: Baseline up to Day 5
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1a-6a: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 1 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 1 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 1 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 1 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 1 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 1 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Constipation | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces soft | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Faeces hard | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) | Diarrhoea | 0 Participants |
Primary
Number of Participants With TEAE Related to Vital Signs
Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute \[bpm\]).
Time frame: Baseline up to Day 5
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1a-6a: Placebo | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAE Related to Vital Signs | 0 Participants |
Primary
Number of Participants With TEAEs Related to Laboratory Tests
Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased.
Time frame: Baseline up to Day 5
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 2 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 1a-6a: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 1 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 1a: TAK-792 30 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 2a: TAK-792 100 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 3a: TAK-792 250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 4a-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 5a-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 6a: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 4a-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 5a-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 5a-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 1 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 1 Participants |
| Cohort 4b-1 - 6b: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 1 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 1 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 1 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 4b-1: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 5b-1: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 1 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 6b: TAK-792 1250 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 4b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 1 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 4b-2: TAK-792 500 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 1 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 5b-2: Placebo | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Protein urine present | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood triglycerides increased | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Aspartate aminotransferase increased | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood bilirubin increased | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood urine present | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | White blood cell count increased | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood creatine phosphokinase increased | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Occult blood positive | 1 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Blood glucose increased | 0 Participants |
| Cohort 5b-2: TAK-792 750 mg | Number of Participants With TEAEs Related to Laboratory Tests | Alanine aminotransferase increased | 0 Participants |
Primary
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to Day 8
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1a-6a: Placebo | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| Cohort 1a: TAK-792 30 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| Cohort 2a: TAK-792 100 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 3a: TAK-792 250 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| Cohort 4a-1: TAK-792 500 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 5a-1: TAK-792 750 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| Cohort 6a: TAK-792 1250 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 4a-2: Placebo | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 4a-2: TAK-792 500 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 5a-2: Placebo | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 5a-2: TAK-792 750 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 4b-1 - 6b: Placebo | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 50.0 percentage of participants |
| Cohort 4b-1: TAK-792 500 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| Cohort 5b-1: TAK-792 750 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 6b: TAK-792 1250 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| Cohort 4b-2: Placebo | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 50.0 percentage of participants |
| Cohort 4b-2: TAK-792 500 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| Cohort 5b-2: Placebo | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 0.0 percentage of participants |
| Cohort 5b-2: TAK-792 750 mg | Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
Secondary
AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Time frame: Day -1: pre-dose and Day 1 (2.5 hours post dose)
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a-6a: Placebo | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1257.10 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 111.299 |
| Cohort 1a-6a: Placebo | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1329.80 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 64.912 |
| Cohort 1a: TAK-792 30 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1372.16 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 62.857 |
| Cohort 1a: TAK-792 30 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1272.66 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 84.565 |
| Cohort 2a: TAK-792 100 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1125.05 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 90.156 |
| Cohort 2a: TAK-792 100 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1305.40 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 172.393 |
| Cohort 3a: TAK-792 250 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1102.43 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 243.948 |
| Cohort 3a: TAK-792 250 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1072.87 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 178.282 |
| Cohort 4a-1: TAK-792 500 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1879.40 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 534.007 |
| Cohort 4a-1: TAK-792 500 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 2307.80 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 568.514 |
| Cohort 5a-1: TAK-792 750 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 2124.73 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 181.829 |
| Cohort 5a-1: TAK-792 750 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1685.08 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 163.129 |
| Cohort 6a: TAK-792 1250 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 2354.00 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 433.174 |
| Cohort 6a: TAK-792 1250 mg | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 2011.75 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 357.018 |
| Cohort 4a-2: Placebo | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1982.10 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 149.745 |
| Cohort 4a-2: Placebo | AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1665.75 micromole*hour per liter (mcmol*hr/L) | Standard Deviation 119.524 |
Secondary
AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Population: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a-6a: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 422.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 22.1 |
| Cohort 1a-6a: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 47.34 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 24.7 |
| Cohort 1a-6a: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 6.765 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 25.9 |
| Cohort 1a: TAK-792 30 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 1324.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 45.7 |
| Cohort 1a: TAK-792 30 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 84.01 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 40.8 |
| Cohort 1a: TAK-792 30 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 350.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 15.7 |
| Cohort 2a: TAK-792 100 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 63.94 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 51.7 |
| Cohort 2a: TAK-792 100 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 521.3 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 24.6 |
| Cohort 2a: TAK-792 100 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 2658.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 57.9 |
| Cohort 3a: TAK-792 250 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 770.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 36.4 |
| Cohort 3a: TAK-792 250 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 3192.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 56.3 |
| Cohort 3a: TAK-792 250 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 128.1 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 27.7 |
| Cohort 4a-1: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 167.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 43.1 |
| Cohort 4a-1: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 998.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 53.2 |
| Cohort 4a-1: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 4909.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 56.2 |
| Cohort 5a-1: TAK-792 750 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 5086.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 78.9 |
| Cohort 5a-1: TAK-792 750 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 1988.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 40.8 |
| Cohort 5a-1: TAK-792 750 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 424.2 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 41.9 |
| Cohort 6a: TAK-792 1250 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 79.70 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 34.2 |
| Cohort 6a: TAK-792 1250 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 357.2 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 44.5 |
| Cohort 6a: TAK-792 1250 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 3237.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 66.9 |
| Cohort 4a-2: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 898.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 28.5 |
| Cohort 4a-2: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 190.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 51.3 |
| Cohort 4a-2: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 5483.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 54.8 |
| Cohort 4a-2: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 610.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 28.3 |
| Cohort 4a-2: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 133.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 39.5 |
| Cohort 4a-2: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 4824.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 38.4 |
| Cohort 5a-2: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 224.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 34.7 |
| Cohort 5a-2: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 6261.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 51.1 |
| Cohort 5a-2: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 622.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 51.8 |
| Cohort 5a-2: TAK-792 750 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 407.9 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 40.7 |
| Cohort 5a-2: TAK-792 750 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 557.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 53.9 |
| Cohort 5a-2: TAK-792 750 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 15430.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 26.7 |
| Cohort 4b-1 - 6b: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 485.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 31.5 |
| Cohort 4b-1 - 6b: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 4813.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 32.9 |
| Cohort 4b-1 - 6b: Placebo | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 97.17 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 36.6 |
| Cohort 4b-1: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-II | 7156.0 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 17.4 |
| Cohort 4b-1: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | M-I | 177.6 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 41 |
| Cohort 4b-1: TAK-792 500 mg | AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 558.2 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 50.3 |
Secondary
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Population: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a-6a: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 392.0 ng*hr/mL | Geometric Coefficient of Variation 24.3 |
| Cohort 1a-6a: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 46.45 ng*hr/mL | Geometric Coefficient of Variation 24.2 |
| Cohort 1a-6a: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 5.912 ng*hr/mL | Geometric Coefficient of Variation 31.6 |
| Cohort 1a: TAK-792 30 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 80.78 ng*hr/mL | Geometric Coefficient of Variation 39.6 |
| Cohort 1a: TAK-792 30 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 346.6 ng*hr/mL | Geometric Coefficient of Variation 15.4 |
| Cohort 1a: TAK-792 30 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 1246.0 ng*hr/mL | Geometric Coefficient of Variation 46 |
| Cohort 2a: TAK-792 100 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 61.32 ng*hr/mL | Geometric Coefficient of Variation 52.1 |
| Cohort 2a: TAK-792 100 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 517.4 ng*hr/mL | Geometric Coefficient of Variation 24.8 |
| Cohort 2a: TAK-792 100 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 2302.0 ng*hr/mL | Geometric Coefficient of Variation 57 |
| Cohort 3a: TAK-792 250 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 767.8 ng*hr/mL | Geometric Coefficient of Variation 36.6 |
| Cohort 3a: TAK-792 250 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 3039.0 ng*hr/mL | Geometric Coefficient of Variation 52.9 |
| Cohort 3a: TAK-792 250 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 119.6 ng*hr/mL | Geometric Coefficient of Variation 22.4 |
| Cohort 4a-1: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 160.5 ng*hr/mL | Geometric Coefficient of Variation 42.8 |
| Cohort 4a-1: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 995.9 ng*hr/mL | Geometric Coefficient of Variation 53.4 |
| Cohort 4a-1: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 4470.0 ng*hr/mL | Geometric Coefficient of Variation 59.3 |
| Cohort 5a-1: TAK-792 750 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 388.6 ng*hr/mL | Geometric Coefficient of Variation 43.3 |
| Cohort 5a-1: TAK-792 750 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 1980.0 ng*hr/mL | Geometric Coefficient of Variation 41 |
| Cohort 5a-1: TAK-792 750 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 4352.0 ng*hr/mL | Geometric Coefficient of Variation 71.2 |
| Cohort 6a: TAK-792 1250 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 3193.0 ng*hr/mL | Geometric Coefficient of Variation 68 |
| Cohort 6a: TAK-792 1250 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 356.2 ng*hr/mL | Geometric Coefficient of Variation 44.6 |
| Cohort 6a: TAK-792 1250 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 74.37 ng*hr/mL | Geometric Coefficient of Variation 34.7 |
| Cohort 4a-2: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 5319.0 ng*hr/mL | Geometric Coefficient of Variation 56.3 |
| Cohort 4a-2: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 182.1 ng*hr/mL | Geometric Coefficient of Variation 53.2 |
| Cohort 4a-2: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 891.9 ng*hr/mL | Geometric Coefficient of Variation 28.7 |
| Cohort 4a-2: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 127.6 ng*hr/mL | Geometric Coefficient of Variation 41.4 |
| Cohort 4a-2: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 608.4 ng*hr/mL | Geometric Coefficient of Variation 28.4 |
| Cohort 4a-2: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 4554.0 ng*hr/mL | Geometric Coefficient of Variation 41.2 |
| Cohort 5a-2: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 214.3 ng*hr/mL | Geometric Coefficient of Variation 36.5 |
| Cohort 5a-2: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 619.2 ng*hr/mL | Geometric Coefficient of Variation 51.8 |
| Cohort 5a-2: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 6030.0 ng*hr/mL | Geometric Coefficient of Variation 54 |
| Cohort 5a-2: TAK-792 750 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 554.9 ng*hr/mL | Geometric Coefficient of Variation 54.1 |
| Cohort 5a-2: TAK-792 750 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 386.8 ng*hr/mL | Geometric Coefficient of Variation 42.4 |
| Cohort 5a-2: TAK-792 750 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 15430.0 ng*hr/mL | Geometric Coefficient of Variation 26.7 |
| Cohort 4b-1 - 6b: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 481.9 ng*hr/mL | Geometric Coefficient of Variation 31.8 |
| Cohort 4b-1 - 6b: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 92.89 ng*hr/mL | Geometric Coefficient of Variation 37.9 |
| Cohort 4b-1 - 6b: Placebo | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 4683.0 ng*hr/mL | Geometric Coefficient of Variation 34.9 |
| Cohort 4b-1: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 169.5 ng*hr/mL | Geometric Coefficient of Variation 41.9 |
| Cohort 4b-1: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 553.6 ng*hr/mL | Geometric Coefficient of Variation 50.9 |
| Cohort 4b-1: TAK-792 500 mg | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 6836.0 ng*hr/mL | Geometric Coefficient of Variation 17.9 |
Secondary
Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Population: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a-6a: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 27.36 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 58.9 |
| Cohort 1a-6a: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 8.916 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 24.2 |
| Cohort 1a-6a: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 1.707 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 30.8 |
| Cohort 1a: TAK-792 30 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 87.07 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 57.9 |
| Cohort 1a: TAK-792 30 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 13.40 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 21.5 |
| Cohort 1a: TAK-792 30 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 59.17 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 29.7 |
| Cohort 2a: TAK-792 100 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 8.786 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 29.9 |
| Cohort 2a: TAK-792 100 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 85.12 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 21.1 |
| Cohort 2a: TAK-792 100 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 110.4 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 70.4 |
| Cohort 3a: TAK-792 250 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 113.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 62.9 |
| Cohort 3a: TAK-792 250 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 105.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 19.1 |
| Cohort 3a: TAK-792 250 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 14.0 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 17.1 |
| Cohort 4a-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 17.13 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 42.6 |
| Cohort 4a-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 140.6 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 52.6 |
| Cohort 4a-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 187.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 24 |
| Cohort 5a-1: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 213.6 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 60.6 |
| Cohort 5a-1: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 267.5 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51.8 |
| Cohort 5a-1: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 37.54 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51.4 |
| Cohort 6a: TAK-792 1250 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 8.401 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 34.5 |
| Cohort 6a: TAK-792 1250 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 57.85 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 48.7 |
| Cohort 6a: TAK-792 1250 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 150.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 27.1 |
| Cohort 4a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 136.4 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 40.8 |
| Cohort 4a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 21.92 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 49.3 |
| Cohort 4a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 218.9 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 60.3 |
| Cohort 4a-2: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 88.44 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 19.8 |
| Cohort 4a-2: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 14.65 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 31.7 |
| Cohort 4a-2: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 134.7 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 33.4 |
| Cohort 5a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 21.73 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 34.7 |
| Cohort 5a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 193.7 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 25.4 |
| Cohort 5a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 97.62 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 59.3 |
| Cohort 5a-2: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 25.15 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 28.8 |
| Cohort 5a-2: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 96.99 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 47 |
| Cohort 5a-2: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 307.5 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 10.5 |
| Cohort 4b-1 - 6b: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 72.22 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 38.2 |
| Cohort 4b-1 - 6b: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 186.4 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 42 |
| Cohort 4b-1 - 6b: Placebo | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 12.86 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 24.5 |
| Cohort 4b-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-II | 352.3 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 39.8 |
| Cohort 4b-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | M-I | 20.04 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 34.3 |
| Cohort 4b-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 86.20 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 40.9 |
Secondary
Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Time frame: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a-6a: Placebo | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 604.90 micromole per liter (mcmol/L) | Standard Deviation 34.365 |
| Cohort 1a-6a: Placebo | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 603.85 micromole per liter (mcmol/L) | Standard Deviation 18.031 |
| Cohort 1a: TAK-792 30 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 605.88 micromole per liter (mcmol/L) | Standard Deviation 60.406 |
| Cohort 1a: TAK-792 30 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 630.64 micromole per liter (mcmol/L) | Standard Deviation 21.031 |
| Cohort 2a: TAK-792 100 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 593.25 micromole per liter (mcmol/L) | Standard Deviation 80.681 |
| Cohort 2a: TAK-792 100 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 483.00 micromole per liter (mcmol/L) | Standard Deviation 47.235 |
| Cohort 3a: TAK-792 250 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 507.08 micromole per liter (mcmol/L) | Standard Deviation 85.66 |
| Cohort 3a: TAK-792 250 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 488.78 micromole per liter (mcmol/L) | Standard Deviation 112.097 |
| Cohort 4a-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 938.00 micromole per liter (mcmol/L) | Standard Deviation 239.285 |
| Cohort 4a-1: TAK-792 500 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1227.00 micromole per liter (mcmol/L) | Standard Deviation 386.222 |
| Cohort 5a-1: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1161.05 micromole per liter (mcmol/L) | Standard Deviation 173.252 |
| Cohort 5a-1: TAK-792 750 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 800.78 micromole per liter (mcmol/L) | Standard Deviation 132.421 |
| Cohort 6a: TAK-792 1250 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1027.25 micromole per liter (mcmol/L) | Standard Deviation 301.157 |
| Cohort 6a: TAK-792 1250 mg | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1227.65 micromole per liter (mcmol/L) | Standard Deviation 212.627 |
| Cohort 4a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 760.93 micromole per liter (mcmol/L) | Standard Deviation 48.105 |
| Cohort 4a-2: Placebo | Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1072.32 micromole per liter (mcmol/L) | Standard Deviation 112.642 |
Secondary
Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II
Time frame: Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Population: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a-6a: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 9.0000 hours | Full Range 58.9 |
| Cohort 1a-6a: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 1.5000 hours | Full Range 30.8 |
| Cohort 1a-6a: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 1.7500 hours | Full Range 24.2 |
| Cohort 1a: TAK-792 30 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 2.0000 hours | Full Range 21.5 |
| Cohort 1a: TAK-792 30 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 11.0000 hours | Full Range 57.9 |
| Cohort 1a: TAK-792 30 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 2.5000 hours | Full Range 29.7 |
| Cohort 2a: TAK-792 100 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 2.5000 hours | Full Range 21.1 |
| Cohort 2a: TAK-792 100 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 1.7500 hours | Full Range 29.9 |
| Cohort 2a: TAK-792 100 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 14.0000 hours | Full Range 70.4 |
| Cohort 3a: TAK-792 250 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 16.0000 hours | Full Range 19.1 |
| Cohort 3a: TAK-792 250 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 2.0000 hours | Full Range 62.9 |
| Cohort 3a: TAK-792 250 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 6.0000 hours | Full Range 17.1 |
| Cohort 4a-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 4.0000 hours | Full Range 52.6 |
| Cohort 4a-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 3.5000 hours | Full Range 42.6 |
| Cohort 4a-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 30.0000 hours | Full Range 24 |
| Cohort 5a-1: TAK-792 750 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 24.0000 hours | Full Range 60.6 |
| Cohort 5a-1: TAK-792 750 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 4.0000 hours | Full Range 51.8 |
| Cohort 5a-1: TAK-792 750 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 4.0000 hours | Full Range 51.4 |
| Cohort 6a: TAK-792 1250 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 3.0000 hours | Full Range 48.7 |
| Cohort 6a: TAK-792 1250 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 3.0000 hours | Full Range 34.5 |
| Cohort 6a: TAK-792 1250 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 24.0000 hours | Full Range 27.1 |
| Cohort 4a-2: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 3.5000 hours | Full Range 49.3 |
| Cohort 4a-2: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 16.0000 hours | Full Range 60.3 |
| Cohort 4a-2: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 3.5000 hours | Full Range 40.8 |
| Cohort 4a-2: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 24.0000 hours | Full Range 33.4 |
| Cohort 4a-2: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 3.0000 hours | Full Range 19.8 |
| Cohort 4a-2: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 2.5000 hours | Full Range 31.7 |
| Cohort 5a-2: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 4.0000 hours | Full Range 59.3 |
| Cohort 5a-2: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 20.0000 hours | Full Range 25.4 |
| Cohort 5a-2: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 5.0000 hours | Full Range 34.7 |
| Cohort 5a-2: TAK-792 750 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 42.0000 hours | Full Range 10.5 |
| Cohort 5a-2: TAK-792 750 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 6.0000 hours | Full Range 28.8 |
| Cohort 5a-2: TAK-792 750 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 3.5000 hours | Full Range 47 |
| Cohort 4b-1 - 6b: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 16.0000 hours | Full Range 42 |
| Cohort 4b-1 - 6b: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 3.0000 hours | Full Range 38.2 |
| Cohort 4b-1 - 6b: Placebo | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 4.0000 hours | Full Range 24.5 |
| Cohort 4b-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-I | 5.0000 hours | Full Range 34.3 |
| Cohort 4b-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | TAK-792F | 3.5000 hours | Full Range 40.9 |
| Cohort 4b-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II | M-II | 16.0000 hours | Full Range 39.8 |
Secondary
Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2
Time frame: Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose
Population: Safety analysis set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1a-6a: Placebo | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1.00 hour |
| Cohort 1a-6a: Placebo | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1.00 hour |
| Cohort 1a: TAK-792 30 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1.00 hour |
| Cohort 1a: TAK-792 30 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1.00 hour |
| Cohort 2a: TAK-792 100 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1.75 hour |
| Cohort 2a: TAK-792 100 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1.75 hour |
| Cohort 3a: TAK-792 250 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 0.75 hour |
| Cohort 3a: TAK-792 250 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 0.75 hour |
| Cohort 4a-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1.00 hour |
| Cohort 4a-1: TAK-792 500 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1.00 hour |
| Cohort 5a-1: TAK-792 750 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1.25 hour |
| Cohort 5a-1: TAK-792 750 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1.00 hour |
| Cohort 6a: TAK-792 1250 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1.25 hour |
| Cohort 6a: TAK-792 1250 mg | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1.00 hour |
| Cohort 4a-2: Placebo | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day 1: Total BCAA | 1.00 hour |
| Cohort 4a-2: Placebo | Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 | Day-1: Total BCAA | 1.00 hour |
Secondary
Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose
Time frame: Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose
Population: PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1a-6a: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.4903 percentage (%) of dose | Standard Deviation 0.12275 |
| Cohort 1a-6a: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 52.2833 percentage (%) of dose | Standard Deviation 9.37452 |
| Cohort 1a-6a: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.5667 percentage (%) of dose | Standard Deviation 0.35517 |
| Cohort 1a: TAK-792 30 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 25.4567 percentage (%) of dose | Standard Deviation 14.21242 |
| Cohort 1a: TAK-792 30 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 1.0367 percentage (%) of dose | Standard Deviation 0.18525 |
| Cohort 1a: TAK-792 30 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.9150 percentage (%) of dose | Standard Deviation 0.72213 |
| Cohort 2a: TAK-792 100 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.8183 percentage (%) of dose | Standard Deviation 1.03695 |
| Cohort 2a: TAK-792 100 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 35.1333 percentage (%) of dose | Standard Deviation 18.44361 |
| Cohort 2a: TAK-792 100 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.6143 percentage (%) of dose | Standard Deviation 0.19055 |
| Cohort 3a: TAK-792 250 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 21.9300 percentage (%) of dose | Standard Deviation 12.94284 |
| Cohort 3a: TAK-792 250 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.4910 percentage (%) of dose | Standard Deviation 0.62949 |
| Cohort 3a: TAK-792 250 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.5128 percentage (%) of dose | Standard Deviation 0.13384 |
| Cohort 4a-1: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 0.9552 percentage (%) of dose | Standard Deviation 0.56474 |
| Cohort 4a-1: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.4733 percentage (%) of dose | Standard Deviation 0.21291 |
| Cohort 4a-1: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 18.1750 percentage (%) of dose | Standard Deviation 7.30395 |
| Cohort 5a-1: TAK-792 750 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 15.2100 percentage (%) of dose | Standard Deviation 11.38256 |
| Cohort 5a-1: TAK-792 750 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.2642 percentage (%) of dose | Standard Deviation 0.51113 |
| Cohort 5a-1: TAK-792 750 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.5477 percentage (%) of dose | Standard Deviation 0.24886 |
| Cohort 6a: TAK-792 1250 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 20.0120 percentage (%) of dose | Standard Deviation 12.08593 |
| Cohort 6a: TAK-792 1250 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.2500 percentage (%) of dose | Standard Deviation 0.12329 |
| Cohort 6a: TAK-792 1250 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 0.6604 percentage (%) of dose | Standard Deviation 0.24546 |
| Cohort 4a-2: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 24.9333 percentage (%) of dose | Standard Deviation 13.03927 |
| Cohort 4a-2: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.0155 percentage (%) of dose | Standard Deviation 0.62088 |
| Cohort 4a-2: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.4484 percentage (%) of dose | Standard Deviation 0.19575 |
| Cohort 4a-2: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 31.8350 percentage (%) of dose | Standard Deviation 17.55999 |
| Cohort 4a-2: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.3955 percentage (%) of dose | Standard Deviation 0.10436 |
| Cohort 4a-2: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.3317 percentage (%) of dose | Standard Deviation 0.85211 |
| Cohort 5a-2: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.1630 percentage (%) of dose | Standard Deviation 0.25033 |
| Cohort 5a-2: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 24.4667 percentage (%) of dose | Standard Deviation 13.80343 |
| Cohort 5a-2: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.2830 percentage (%) of dose | Standard Deviation 0.16074 |
| Cohort 5a-2: TAK-792 750 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.1715 percentage (%) of dose | Standard Deviation 0.07766 |
| Cohort 5a-2: TAK-792 750 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 1.1442 percentage (%) of dose | Standard Deviation 0.31888 |
| Cohort 5a-2: TAK-792 750 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 39.4167 percentage (%) of dose | Standard Deviation 9.21421 |
| Cohort 4b-1 - 6b: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 0.6330 percentage (%) of dose | Standard Deviation 0.32789 |
| Cohort 4b-1 - 6b: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.2755 percentage (%) of dose | Standard Deviation 0.08876 |
| Cohort 4b-1 - 6b: Placebo | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 22.5383 percentage (%) of dose | Standard Deviation 15.47892 |
| Cohort 4b-1: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | TAK-792F | 0.2870 percentage (%) of dose | Standard Deviation 0.14673 |
| Cohort 4b-1: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-I | 0.7723 percentage (%) of dose | Standard Deviation 0.24873 |
| Cohort 4b-1: TAK-792 500 mg | Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose | M-II | 26.7167 percentage (%) of dose | Standard Deviation 8.29516 |