INDV-2000 First in Human

NCT04413552 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: INDV-2000-101UG3DA050308
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Secondary Outcomes (26)

• 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).

• 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).

• 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).

• 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).

• 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

Study Arms (3)

Part I: INDV-2000

EXPERIMENTAL

Participants will receive a single dose of INDV-2000. The starting dose is 1 mg with dose escalation dependent upon observed clinical safety, tolerability and pharmacokinetics.

Drug: INDV-2000

Part I: Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of matching placebo.

Drug: Placebo

Part II: INDV-2000 Fasted/Fed

EXPERIMENTAL

Participants will receive a single dose of INDV-2000 orally on Day 1 under fasted conditions and a single dose of INDV-2000 after a high-fat breakfast on Day 8. Dose to be determined based on a well-tolerated dose studied in Part I.

Drug: INDV-2000

Interventions

INDV-2000 DRUG

INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered.

Also known as: C4X_3256

Part I: INDV-2000; Part II: INDV-2000 Fasted/Fed

Placebo DRUG

Placebo will be administered as either powder in solution or powder in capsule, depending on dose administered.

Part I: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Altasciences Clinical Kansas

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Global Director, Clinical Development
• Organization: Indivior, Inc.

TrialDisclosure@Indivior.com

804-594-4488

Study Officials

• Martin Kankam

  Altasciences Company Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part I: Double-blind; Part II: Open-label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 4, 2020
• Study Start: July 6, 2020
• Primary Completion: April 13, 2021
• Study Completion: April 13, 2021
• Last Updated: May 16, 2024
• Results First Posted: September 28, 2022

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)