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Opioid DependencePhase 1NCT04413552

INDV-2000 First in Human

A Phase 1 study testing INDV-2000 in people with Opioid Dependence, 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

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Opioid Dependence
What is being tested?
INDV-2000
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
1 siteUnited States
Study dates
6 Jul 2020to 13 Apr 2021
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

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altasciences Clinical Kansas

    Overland Park, Kansas, 66212

Other trials in United States

About this study

Official title: A Phase I, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers

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.

Being tested
INDV-2000, Placebo
Medical subject headings
Opioid-Related Disorders

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

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

  • PlaceboDrug

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

Study groups in NCT04413552
Study groupRoleWhat they receive
Part I: INDV-2000ExperimentalParticipants 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.
Receives: Drug: INDV-2000
Part I: PlaceboPlacebo comparatorParticipants will receive a single dose of matching placebo.
Receives: Drug: Placebo
Part II: INDV-2000 Fasted/FedExperimentalParticipants 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.
Receives: Drug: INDV-2000

What is being measured

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

  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.

    Measured: 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)

  1. Number of Participants With Clinically Significant Laboratory Findings

    The investigator assessed abnormal laboratory values to determine clinical significance.

    Measured: 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).

  2. 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.

    Measured: 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).

  3. Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

    The investigator assessed abnormal ECG values to determine clinical significance.

    Measured: 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).

  4. 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.

    Measured: 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).

  5. 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.

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  6. Part I: Time to Maximum Observed Plasma Concentration (Tmax) of INDV-2000 After a Single Dose

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  7. 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

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  8. Part I: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of INDV-2000 After A Single Dose

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  9. Part I: Apparent Plasma Clearance (CL/F) of INDV-2000 After a Single Dose

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  10. Part I: Plasma Terminal Half-life of INDV-2000 After a Single Dose

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  11. 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.

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  12. Part I: Time to Maximum Observed Plasma Concentration (Tmax) of M12 After a Single Dose of INDV-2000

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  13. 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

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  14. 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

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  15. Part I: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000

    Measured: Day 1 pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose

  16. Part II: Cmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions

    Measured: 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

  17. Part II: Tmax of INDV-2000 After a Single Dose Under Fasting and Fed Conditions

    Measured: 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

  18. Part II: AUC0-last of INDV-2000 After a Single Dose Under Fasting and Fed Conditions

    Measured: 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

  19. Part II: AUC0-inf of INDV-2000 After a Single Dose Under Fasting and Fed Conditions

    Measured: 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

  20. Part II: Apparent Clearance of INDV-2000 After a Single Dose Under Fasting and Fed Conditions

    Measured: 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

  21. Part II: Plasma Terminal Half-life of INDV-2000 After a Single Dose Under Fasting and Fed Conditions

    Measured: 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

  22. Part II: Cmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions

    Measured: 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

  23. Part II: Tmax of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions

    Measured: 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

  24. Part II: AUC0-last of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions

    Measured: 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

  25. Part II: AUC0-inf of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions

    Measured: 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

  26. Part II: Plasma Terminal Half-life of M12 After a Single Dose of INDV-2000 Under Fasting and Fed Conditions

    Measured: 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

Timeline

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

  1. First posted4 Jun 2020
  2. Study start6 Jul 2020
  3. Primary completion13 Apr 2021
  4. Study completion13 Apr 2021

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
Randomised
Intervention model
Sequential
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04413552
Sponsor's protocol ID
INDV-2000-101
Other IDs
UG3DA050308
Status last verified
May 2024
First submitted
21 May 2020
Last updated
16 May 2024
Data monitoring committee
Yes
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 in people with Opioid Dependence, 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 5 inclusion and 19 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 16 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. Some participants in this study may receive a placebo. 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 28 Sep 2022). 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?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (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).). 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 NCT04413552.

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 16 May 2024.

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