Study of Potential CYP3A4 Induction by INDV-2000 in Healthy Adults

NCT05694533 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: INDV-2000-104UG3DA050308
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the potential for cytochrome P450 (CYP) 3A4 induction after dosing with INDV-2000 via use of midazolam as a probe.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam

  Day 1 and Day 15

• Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Midazolam and 1-hydroxymidazolam

  Day 1 and Day 15

• Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam and 1-hydroxymidazolam

  Day 1 and Day 15

Secondary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  From first dose of study drug to Day 22

Study Arms (1)

INDV-2000 BID + Midazolam

EXPERIMENTAL

Participants will receive a single oral dose of 5 mg midazolam on Day 1. Participants will receive a dose of INDV-2000 twice a day (BID) from Days 2 to 15. On Day 15 participants will also receive a single oral dose of 5 mg midazolam co-administered with the INDV-2000 morning dose.

Drug: INDV-2000; Drug: Midazolam

Interventions

INDV-2000 DRUG

Capsules administered orally twice a day

Also known as: C4X_3256

INDV-2000 BID + Midazolam

Midazolam DRUG

Midazolam syrup administered orally on Days 1 and 15

INDV-2000 BID + Midazolam

Eligibility Criteria

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

You may qualify if:

• Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
• Body weight of a minimum of 50.0 kg at the screening visit and body mass index within the range 18.0 - 32.0 kg/m\^2 (inclusive).
• Male or female who is healthy as determined by medical evaluation.
• Females will be of non-childbearing potential. Females of non-childbearing potential are considered women who:
• Do not have a uterus, or
• Are surgically sterile (eg, has undergone complete hysterectomy, bilateral oophorectomy, hysteroscopic sterilization, or tubal ligation), or
• Have permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries, or
• Are post-menopausal as defined by 12 months or more of spontaneous amenorrhea as confirmed by a follicle-stimulating hormone (FSH) \> 30 mIU/mL
• Male participants agree to follow contraception guidelines specified in the Protocol.
• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
• Capable of giving signed informed consent.

You may not qualify if:

• Have an ongoing medical history of clinically significant neurological, cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal (GI) disease, psychiatric or other disorder as judged by an Investigator that could potentially affect the study outcomes or compromise participant safety.
• Have clinically significant abnormal biochemistry, hematology or urinalysis results as judged by an Investigator.
• Have a history of narcolepsy or sleep apnea.
• Have disorders that may interfere with drug absorption, distribution, metabolism and excretion processes.
• Current active hepatic or biliary disease.
• Participants with cholecystectomy \< 90 days prior to screening.
• Positive test results for human immunodeficiency virus (HIV)-1/HIV-2 antibodies, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies.
• Have a blood pressure reading outside of the following range: Systolic \< 86 or \> 149 mmHg; Diastolic \< 50 or \> 94 mmHg
• Serious cardiac illness or other medical condition including, but not limited to:
• Uncontrolled arrhythmias
• History of congestive heart failure
• QTcF \> 450 msec for males and \> 470 msec for females or history of prolonged QT syndrome
• Myocardial infarction
• Uncontrolled symptomatic angina
• History of suicidal ideation within 30 days prior to providing written informed consent as evidenced by answering "yes' to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at the screening visit or history of a suicide attempt (per the C-SSRS) in the 6 months prior to informed consent.

Sponsors & Collaborators

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

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

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

trialdisclosure@indivior.com

(804) 594-4488

Study Officials

• Danielle Armas, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: March 16, 2023
• Primary Completion: April 6, 2023
• Study Completion: May 1, 2023
• Last Updated: May 28, 2024
• Results First Posted: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)