Opioid Dependence
Conditions
Brief summary
This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will be conducted.
Interventions
DRUGINDV-2000
INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered.
DRUGPlacebo
Placebo will be administered as either powder in solution or powder in capsule, depending on dose administered.
Sponsors
National Institute on Drug Abuse (NIDA)
Indivior Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Part I: Double-blind; Part II: Open-label
Intervention model description
Part I - sequential escalating dose cohorts; within each dose cohort participants will be randomized to INDV-2000 or matching placebo in a 3:1 ratio. Part II - single cohort crossover study in which participants will receive INDV-2000 on 2 occasions separated by a 1-week washout period, once under fasting conditions and once after a standard high-fat breakfast.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be able to verbalize understanding the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, and be able to comply with protocol requirements, rules and regulations of the study site, and be likely to complete all the study interventions. * Must be considered a healthy male or non-childbearing female for Part I * For Part II, must be a healthy male who did not participate in Part I and willing to consume a high-fat meal. * Body mass index (BMI) within 18.0 to 30.0 kg/m\^2, inclusive (minimum weight of at least 50.0 kg at Screening) * Male subjects who are sexually active with female partners of child-bearing potential must use, with their partner, a condom plus an approved method of effective contraception from time of screening until 90 days after last dose of Investigational Medicinal Product (IMP). Additionally, male subjects must agree to not donate sperm during the study and for at least 90 days from last dose of IMP.
Exclusion criteria
* Have a medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder as judged by an Investigator, * Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator, * Have a history of narcolepsy or other significant sleep disorders * Have disorders that may interfere with drug absorption, distribution, metabolism and excretion (ADME) processes, * Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb). * Serious cardiac illness or other medical condition including, but not limited to: Uncontrolled arrhythmias; History of congestive heart failure (CHF); myocardial infarction \< 6 months from receipt of first dose of IMP; uncontrolled symptomatic angina; corrected QT value (QTcF) \> 450 msec for males and \> 470 msec for females or history of prolonged QT syndrome; Have a blood pressure reading outside of the following range: systolic \< 86 or \> 149 mmHg; diastolic \< 50 or \> 94 mmHg * Current active hepatic or biliary disease. Subjects with cholecystectomy \< 90 days prior to screening. * Regular alcohol consumption in males \> 21 units per week and females \> 14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine). * Positive test result for alcohol and/or drugs of abuse at screening or prior to the first IMP administration. * Current smokers and those who have smoked within the last 90 days. Current users of e-cigarettes and nicotine replacement products, and those who have used these products within the last 90 days. * Concurrent treatment or treatment with an investigational drug within 30 days prior to the first dose. * Blood donation of approximately 500 mL within 56 days or plasma donation within 7 days of screening. * Subjects who are taking, or have taken, any prescribed or over-the-counter drugs (other than 2 g per day acetaminophen, hormone replacement therapy, hormonal contraception) or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis if considered not to interfere with the objectives of the study, as agreed by an Investigator and Sponsor's Medical Monitor. * Any consumption of food or drink containing poppy seeds, grapefruit or Seville oranges within 7 days prior to the IMP administration * Treatment with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) 3A4 within 30 days prior to first dose of IMP. * Known allergy or hypersensitivity to IMP or its excipients. * Any condition that, in the opinion of an Investigator, would interfere with evaluation of the IMP or interpretation of subject safety or study results. * Affiliated with, or a family member of, site staff directly involved in the study, or anyone with a financial interest in the outcome of the study. * Subjects who are unable, in the opinion of an Investigator, to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions). | An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs | From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions). | The investigator assessed changes in vital signs (including including blood pressure, respiratory rate, heart rate and temperature) to determine clinical significance. |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions). | The investigator assessed abnormal ECG values to determine clinical significance. |
| Number of Participants With Clinically Significant Physical Examination Findings | From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions). | Any clinically significant abnormalities observed during physical examination, including changes from baseline, were recorded as adverse events on the adverse event (AE) case report form (CRF) and are reported in the adverse events section of results below. However, these events were not recorded as physical examination findings. Therefore, clinically significant physical examination findings can not be reported separately. |
| Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | Concentrations of INDV-2000 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters based on the actual sample collection times were derived using standard non-compartmental methods. |
| Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | Concentrations of INDV-2000 metabolite M12 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. |
| Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Number of Participants With Clinically Significant Laboratory Findings | From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions). | The investigator assessed abnormal laboratory values to determine clinical significance. |
| Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
| Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose | — |
Countries
United States
Participant flow
Recruitment details
Healthy volunteers were enrolled at a single site in Overland Park, Kansas, United States.
Pre-assignment details
This study was conducted in 2 parts: Part I was a double-blind, placebo-controlled, randomized, single ascending dose (SAD) study in which participants were randomized in cohorts of 8 subjects with 6 subjects receiving active drug and 2 subjects receiving placebo. Part II was an open-label, cross-over, food interaction, single-dose study with INDV-2000 administered once under fasting conditions and once after completion of a standard high-fat breakfast.
Participants by arm
| Arm | Count |
|---|---|
| Part I: INDV-2000 1 mg Participants received a single dose of 1 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: INDV-2000 5 mg Participants received a single dose of 5 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: INDV-2000 20 mg Participants received a single dose of 20 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: INDV-2000 50 mg Participants received a single dose of 50 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: INDV-2000 120 mg Participants received a single dose of 120 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: INDV-2000 180 mg Participants received a single dose of 180 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: INDV-2000 360 mg Participants received a single dose of 360 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: INDV-2000 720 mg Participants received a single dose of 720 mg INDV-2000 orally under fasted conditions on Day 1. | 6 |
| Part I: Pooled Placebo Participants received a single dose of matching placebo orally under fasted conditions on Day 1. | 16 |
| Part II: INDV-2000 360 mg Fasted/Fed Participants received a single dose of 360 mg INDV-2000 orally on Day 1 under fasted conditions and a single dose of 360 mg INDV-2000 after a high-fat breakfast on Day 8. | 8 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Part I: INDV-2000 1 mg | Part I: INDV-2000 5 mg | Part I: INDV-2000 20 mg | Part I: INDV-2000 50 mg | Part I: INDV-2000 120 mg | Part I: INDV-2000 180 mg | Part I: INDV-2000 360 mg | Part I: INDV-2000 720 mg | Part I: Pooled Placebo | Total | Part II: INDV-2000 360 mg Fasted/Fed |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Part I | 42.0 years STANDARD_DEVIATION 12.05 | 42.2 years STANDARD_DEVIATION 12.8 | 34.3 years STANDARD_DEVIATION 4.41 | 40.5 years STANDARD_DEVIATION 10.93 | 33.5 years STANDARD_DEVIATION 11.2 | 31.5 years STANDARD_DEVIATION 12.36 | 44.3 years STANDARD_DEVIATION 6.74 | 31.8 years STANDARD_DEVIATION 11.34 | 36.5 years STANDARD_DEVIATION 11.49 | 37.3 years STANDARD_DEVIATION 11.02 | — |
| Age, Continuous Part II | — | — | — | — | — | — | — | — | — | 40.4 years STANDARD_DEVIATION 7.52 | 40.4 years STANDARD_DEVIATION 7.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 6 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 4 Participants | 5 Participants | 6 Participants | 5 Participants | 15 Participants | 66 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 4 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 4 Participants | 9 Participants | 32 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 2 Participants | 1 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 7 Participants | 36 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 14 Participants | 0 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 5 Participants | 13 Participants | 58 Participants | 8 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 16 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 2 / 6 | 3 / 6 | 3 / 6 | 2 / 6 | 3 / 6 | 1 / 6 | 4 / 6 | 2 / 16 | 4 / 8 | 4 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 16 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was considered related to study drug if it could not reasonably be explained by other factors. A serious AE is any event that met any of the following criteria: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other important medical event that may have jeopardized the participant or required an intervention to prevent an above outcome. A severe AE describes the intensity of an AE, defined as causing marked limitation in activity; medical intervention or therapy or hospitalization required. For vital sign and laboratory abnormalities assessed as AEs, intensity was graded in accordance with the Food and Drug Administration Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, where Grade 3 = serious and Grade 4 = potentially life-threatening.
Time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
Population: Participants who received at least one dose of study drug (safety population)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 0 Participants |
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 0 Participants |
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: INDV-2000 1 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 2 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 3 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 1 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 1 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 2 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 3 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 1 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 2 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 1 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 1 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 3 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 1 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 1 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 1 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 4 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 4 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 2 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 4 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 4 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Fatal TEAE | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Any treatment-emergent adverse event (TEAE) | 4 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TEAE | 3 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Treatment-emergent serious adverse events (TESAE) | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Drug-related TESAE | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Severe TEAE | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE with grade 3 or higher toxicity | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | TEAE leading to discontinuation | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes in Vital Signs
The investigator assessed changes in vital signs (including including blood pressure, respiratory rate, heart rate and temperature) to determine clinical significance.
Time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part 1 and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
Population: Participants who received at least one dose of study drug (safety population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part I: INDV-2000 1 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 1 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Clinically Significant Changes in Vital Signs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
The investigator assessed abnormal ECG values to determine clinical significance.
Time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
Population: Participants who received at least one dose of study drug (safety population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part I: INDV-2000 1 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part I: Pooled Placebo | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 0 Participants |
Secondary
Number of Participants With Clinically Significant Laboratory Findings
The investigator assessed abnormal laboratory values to determine clinical significance.
Time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
Population: Participants who received at least one dose of study drug (safety population)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part I: INDV-2000 1 mg | Number of Participants With Clinically Significant Laboratory Findings | 0 Participants |
| Part I: INDV-2000 5 mg | Number of Participants With Clinically Significant Laboratory Findings | 0 Participants |
| Part I: INDV-2000 20 mg | Number of Participants With Clinically Significant Laboratory Findings | 2 Participants |
| Part I: INDV-2000 50 mg | Number of Participants With Clinically Significant Laboratory Findings | 2 Participants |
| Part I: INDV-2000 120 mg | Number of Participants With Clinically Significant Laboratory Findings | 1 Participants |
| Part I: INDV-2000 180 mg | Number of Participants With Clinically Significant Laboratory Findings | 0 Participants |
| Part I: INDV-2000 360 mg | Number of Participants With Clinically Significant Laboratory Findings | 0 Participants |
| Part I: INDV-2000 720 mg | Number of Participants With Clinically Significant Laboratory Findings | 1 Participants |
| Part I: Pooled Placebo | Number of Participants With Clinically Significant Laboratory Findings | 2 Participants |
| Part II Period 1: INDV-2000 360 mg Fasted | Number of Participants With Clinically Significant Laboratory Findings | 0 Participants |
| Part II Period 2: INDV-2000 360 mg Fed | Number of Participants With Clinically Significant Laboratory Findings | 0 Participants |
Secondary
Number of Participants With Clinically Significant Physical Examination Findings
Any clinically significant abnormalities observed during physical examination, including changes from baseline, were recorded as adverse events on the adverse event (AE) case report form (CRF) and are reported in the adverse events section of results below. However, these events were not recorded as physical examination findings. Therefore, clinically significant physical examination findings can not be reported separately.
Time frame: From first dose of study drug to end of study participation for each cohort; 11 days in Part I and 7 days in Part II, Period 1 (fasted conditions) and 10 days in Part II, Period 2 (fed conditions).
Population: Clinically significant physical examination findings were not recorded separately.
Secondary
Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 15.4 L/h | Standard Deviation 4.31 |
| Part I: INDV-2000 5 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 18.8 L/h | Standard Deviation 6.98 |
| Part I: INDV-2000 20 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 23.2 L/h | Standard Deviation 6.7 |
| Part I: INDV-2000 50 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 24.5 L/h | Standard Deviation 9.67 |
| Part I: INDV-2000 120 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 22.4 L/h | Standard Deviation 11.7 |
| Part I: INDV-2000 180 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 21.7 L/h | Standard Deviation 4.03 |
| Part I: INDV-2000 360 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 25.8 L/h | Standard Deviation 13.4 |
| Part I: INDV-2000 720 mg | Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose | 26.7 L/h | Standard Deviation 7.78 |
Secondary
Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 69.5 ng*h/mL | Standard Deviation 19.1 |
| Part I: INDV-2000 5 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 317 ng*h/mL | Standard Deviation 180 |
| Part I: INDV-2000 20 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 907 ng*h/mL | Standard Deviation 207 |
| Part I: INDV-2000 50 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 2350 ng*h/mL | Standard Deviation 1030 |
| Part I: INDV-2000 120 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 6920 ng*h/mL | Standard Deviation 4060 |
| Part I: INDV-2000 180 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 8530 ng*h/mL | Standard Deviation 1590 |
| Part I: INDV-2000 360 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 17800 ng*h/mL | Standard Deviation 9810 |
| Part I: INDV-2000 720 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose | 28700 ng*h/mL | Standard Deviation 7810 |
Secondary
Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 74.8 ng*h/mL | Standard Deviation 30.3 |
| Part I: INDV-2000 5 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 417 ng*h/mL | Standard Deviation 222 |
| Part I: INDV-2000 20 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 1310 ng*h/mL | Standard Deviation 489 |
| Part I: INDV-2000 50 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 3200 ng*h/mL | Standard Deviation 2240 |
| Part I: INDV-2000 120 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 10100 ng*h/mL | Standard Deviation 4370 |
| Part I: INDV-2000 180 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 10100 ng*h/mL | Standard Deviation 5540 |
| Part I: INDV-2000 360 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 24000 ng*h/mL | Standard Deviation 16200 |
| Part I: INDV-2000 720 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M12 After A Single Dose of INDV-2000 | 25800 ng*h/mL | Standard Deviation 6110 |
Secondary
Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 67.3 ng*h/mL | Standard Deviation 17.7 |
| Part I: INDV-2000 5 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 312 ng*h/mL | Standard Deviation 181 |
| Part I: INDV-2000 20 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 915 ng*h/mL | Standard Deviation 186 |
| Part I: INDV-2000 50 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 2340 ng*h/mL | Standard Deviation 1020 |
| Part I: INDV-2000 120 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 6900 ng*h/mL | Standard Deviation 4050 |
| Part I: INDV-2000 180 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 8520 ng*h/mL | Standard Deviation 1600 |
| Part I: INDV-2000 360 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 17800 ng*h/mL | Standard Deviation 9800 |
| Part I: INDV-2000 720 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-last) of INDV-2000 After A Single Dose | 28700 ng*h/mL | Standard Deviation 7810 |
Secondary
Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 72.8 ng*h/mL | Standard Deviation 28.8 |
| Part I: INDV-2000 5 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 413 ng*h/mL | Standard Deviation 223 |
| Part I: INDV-2000 20 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 1300 ng*h/mL | Standard Deviation 489 |
| Part I: INDV-2000 50 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 3190 ng*h/mL | Standard Deviation 2250 |
| Part I: INDV-2000 120 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 10000 ng*h/mL | Standard Deviation 4370 |
| Part I: INDV-2000 180 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 10100 ng*h/mL | Standard Deviation 5540 |
| Part I: INDV-2000 360 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 24000 ng*h/mL | Standard Deviation 16200 |
| Part I: INDV-2000 720 mg | Part I: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration of M12 After A Single Dose of INDV-2000 | 25800 ng*h/mL | Standard Deviation 6120 |
Secondary
Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 21.2 L/hr | Standard Deviation 9.61 |
| Part I: INDV-2000 5 mg | Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 24.1 L/hr | Standard Deviation 9.04 |
Secondary
Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 19700 ng*hr/mL | Standard Deviation 7690 |
| Part I: INDV-2000 5 mg | Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 17400 ng*hr/mL | Standard Deviation 8130 |
Secondary
Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 18200 ng*hr/mL | Standard Deviation 4030 |
| Part I: INDV-2000 5 mg | Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 15800 ng*hr/mL | Standard Deviation 4300 |
Secondary
Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 18200 ng*hr/mL | Standard Deviation 6060 |
| Part I: INDV-2000 5 mg | Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 16700 ng*hr/mL | Standard Deviation 7970 |
Secondary
Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 15800 ng*hr/mL | Standard Deviation 4180 |
| Part I: INDV-2000 5 mg | Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 15000 ng*hr/mL | Standard Deviation 3920 |
Secondary
Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 1700 ng/mL | Standard Deviation 584 |
| Part I: INDV-2000 5 mg | Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 2720 ng/mL | Standard Deviation 796 |
Secondary
Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 1320 ng/mL | Standard Deviation 243 |
| Part I: INDV-2000 5 mg | Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 1500 ng/mL | Standard Deviation 277 |
Secondary
Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 6.37 hours | Standard Deviation 1.62 |
| Part I: INDV-2000 5 mg | Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 2.91 hours | Standard Deviation 0.76 |
Secondary
Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 7.43 hours | Standard Deviation 1.13 |
| Part I: INDV-2000 5 mg | Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 5.21 hours | Standard Deviation 1.24 |
Secondary
Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part I: INDV-2000 1 mg | Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 3.00 hours |
| Part I: INDV-2000 5 mg | Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions | 3.00 hours |
Secondary
Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions
Time frame: Day 1 and Day 8 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: The food effect PK population included the subset of Part II participants in the PK population who had at least one evaluable PK parameter for at least one meal condition.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part I: INDV-2000 1 mg | Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 4.00 hours |
| Part I: INDV-2000 5 mg | Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions | 4.00 hours |
Secondary
Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose
Concentrations of INDV-2000 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters based on the actual sample collection times were derived using standard non-compartmental methods.
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters (PK population).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 16.7 ng/mL | Standard Deviation 3.93 |
| Part I: INDV-2000 5 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 87.6 ng/mL | Standard Deviation 26.4 |
| Part I: INDV-2000 20 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 194 ng/mL | Standard Deviation 33.3 |
| Part I: INDV-2000 50 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 489 ng/mL | Standard Deviation 147 |
| Part I: INDV-2000 120 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 1000 ng/mL | Standard Deviation 343 |
| Part I: INDV-2000 180 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 1100 ng/mL | Standard Deviation 238 |
| Part I: INDV-2000 360 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 1880 ng/mL | Standard Deviation 1140 |
| Part I: INDV-2000 720 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of INDV-2000 After a Single Dose | 2080 ng/mL | Standard Deviation 688 |
Secondary
Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000
Concentrations of INDV-2000 metabolite M12 were measured using a validated high-performance liquid chromatography with electrospray tandem Mass spectrometry (LC-MS/MS) method.
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 12.2 ng/mL | Standard Deviation 3.31 |
| Part I: INDV-2000 5 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 76.4 ng/mL | Standard Deviation 14.4 |
| Part I: INDV-2000 20 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 182 ng/mL | Standard Deviation 34 |
| Part I: INDV-2000 50 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 372 ng/mL | Standard Deviation 113 |
| Part I: INDV-2000 120 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 983 ng/mL | Standard Deviation 121 |
| Part I: INDV-2000 180 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 963 ng/mL | Standard Deviation 326 |
| Part I: INDV-2000 360 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 1650 ng/mL | Standard Deviation 536 |
| Part I: INDV-2000 720 mg | Part I: Maximum Observed Plasma Concentration (Cmax) of M12 After a Single Dose of INDV-2000 | 1840 ng/mL | Standard Deviation 318 |
Secondary
Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 2.19 hours | Standard Deviation 0.32 |
| Part I: INDV-2000 5 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 2.52 hours | Standard Deviation 0.46 |
| Part I: INDV-2000 20 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 2.56 hours | Standard Deviation 0.37 |
| Part I: INDV-2000 50 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 2.81 hours | Standard Deviation 0.47 |
| Part I: INDV-2000 120 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 3.56 hours | Standard Deviation 1.18 |
| Part I: INDV-2000 180 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 3.47 hours | Standard Deviation 0.46 |
| Part I: INDV-2000 360 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 4.57 hours | Standard Deviation 0.58 |
| Part I: INDV-2000 720 mg | Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose | 5.28 hours | Standard Deviation 2.18 |
Secondary
Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of pharmacokinetic (PK) samples collected to derive PK parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 3.78 hours | Standard Deviation 0.84 |
| Part I: INDV-2000 5 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 4.04 hours | Standard Deviation 0.73 |
| Part I: INDV-2000 20 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 3.93 hours | Standard Deviation 0.5 |
| Part I: INDV-2000 50 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 4.23 hours | Standard Deviation 1.21 |
| Part I: INDV-2000 120 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 4.51 hours | Standard Deviation 0.81 |
| Part I: INDV-2000 180 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 4.45 hours | Standard Deviation 0.56 |
| Part I: INDV-2000 360 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 5.54 hours | Standard Deviation 1.07 |
| Part I: INDV-2000 720 mg | Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 | 5.87 hours | Standard Deviation 2.08 |
Secondary
Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 1.00 hours |
| Part I: INDV-2000 5 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 0.50 hours |
| Part I: INDV-2000 20 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 2.50 hours |
| Part I: INDV-2000 50 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 2.02 hours |
| Part I: INDV-2000 120 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 2.00 hours |
| Part I: INDV-2000 180 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 3.50 hours |
| Part I: INDV-2000 360 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 2.00 hours |
| Part I: INDV-2000 720 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose | 3.00 hours |
Secondary
Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000
Time frame: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose
Population: Participants who received at least one dose of INDV-2000 and had an adequate number of PK samples collected to derive PK parameters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part I: INDV-2000 1 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 1.08 hours |
| Part I: INDV-2000 5 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 0.50 hours |
| Part I: INDV-2000 20 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 3.50 hours |
| Part I: INDV-2000 50 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 2.52 hours |
| Part I: INDV-2000 120 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 3.00 hours |
| Part I: INDV-2000 180 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 4.00 hours |
| Part I: INDV-2000 360 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 3.00 hours |
| Part I: INDV-2000 720 mg | Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000 | 3.00 hours |