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HealthyPhase 1NCT05694533

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

A Phase 1 study testing INDV-2000 and Midazolam in people with Healthy, run by Indivior Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
INDV-2000 and Midazolam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
16 Mar 2023to 1 May 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Healthy participants who are taking, or have taken, any prescribed or over-the-counter drugs (other than 2 grams of acetaminophen per 24-hour period as of Day 1, hormone replacement therapy, or thyroid hormone replacement therapy) or herbal remedies in the 14 days or 5 half-lives (whichever is longer) prior to first dose of study drug.
  • Treatment with any known drugs that are moderate or strong inhibitors/inducers of CYP3A4 or CYP2C19, including St. John's Wort, within 30 days prior to first dose of study drug.
  • Any consumption of food or drink containing poppy seeds, grapefruit or Seville oranges within 14 days prior to the first dose of study drug.
  • 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 at check-in.
  • Female participant with a positive pregnancy test at the screening visit or at first check-in or who are lactating.
  • Concurrent treatment or treatment with an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.
  • Blood donation of approximately 500 mL or more within 56 days or plasma donation within 7 days of screening.
  • Known hypersensitivity to INDV-2000 or any other ingredient in the INDV-2000 formulation.
  • Known hypersensitivity to midazolam or any other ingredient in midazolam HCl syrup.
  • Site staff and/or participants who have a financial interest in, or an immediate family member of either the site staff and/or Indivior employees, directly involved in the study.
  • Major surgical procedure (as defined by the Investigator) within 90 days prior to the first dose of study drug or still recovering from prior surgery.
  • Concurrent enrollment in another clinical study, unless it is an observational study.
  • Participants who are unable, in the opinion of the Investigator, to comply fully with the study requirements.
  • Any condition that, in the opinion of the Investigator or Indivior, would interfere with evaluation of the study drug or interpretation of participant safety or study results.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion

    Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: An Open Label, Fixed-sequence Study to Evaluate the Potential CYP3A4 Induction Effect of INDV-2000 Using Oral Midazolam as a Probe in Healthy Adults Participants

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
Being tested
INDV-2000, Midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INDV-2000Drug

    Also called C4X_3256

    Capsules administered orally twice a day

  • MidazolamDrug

    Midazolam syrup administered orally on Days 1 and 15

Study groups in NCT05694533
Study groupRoleWhat they receive
INDV-2000 BID + MidazolamExperimentalParticipants 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.
Receives: Drug: INDV-2000; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 and Day 15

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

    Measured: Day 1 and Day 15

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

    Measured: Day 1 and Day 15

Secondary outcomes (1)

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

    TEAEs will be defined as adverse events that start on or after the first dose of study drug.

    Measured: From first dose of study drug to Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2023
  2. Study start16 Mar 2023
  3. Primary completion6 Apr 2023
  4. Study completion1 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05694533
Sponsor's protocol ID
INDV-2000-104
Other IDs
UG3DA050308
Status last verified
May 2024
First submitted
12 Jan 2023
Last updated
28 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INDV-2000 and Midazolam in people with Healthy, run by Indivior Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Midazolam and 1-hydroxymidazolam (time frame: Day 1 and Day 15). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05694533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

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