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INDV-2000 First in Human

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ClinicalTrials.gov Identifier: NCT04413552
Recruitment Status : Completed
First Posted : June 4, 2020
Last Update Posted : April 19, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Indivior Inc.

Tracking Information
First Submitted Date  ICMJE May 21, 2020
First Posted Date  ICMJE June 4, 2020
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE July 6, 2020
Actual Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
Safety of single doses of INDV-2000 as determined by adverse event reporting [ Time Frame: Adverse events will be measured from time of informed consent to end of study participation for each cohort (up to 45 days) ]
Occurrence of any adverse event
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • Incidence of treatment emergent adverse events (TEAEs) as measured by clinically significant changes in laboratory values [ Time Frame: Labs will be assessed from screening until the end of subject participation (end of study or early termination visit as applicable), up to 45 days from the screening visit. ]
    Observed values and changes from baseline in clinical laboratory parameters will be summarized by analysis visit (frequency and percentages for each category). Clinically significant changes from baseline requiring additional assessment or treatment will be reported as adverse events.
  • Incidence of TEAEs as measured by changes in electrocardiogram (ECG) intervals [ Time Frame: Electrocardiographic assessments will be performed at screening, and intermittently until the end of subject participation (end of study or early termination visit as applicable), up to 45 days from the screening visit ]
    Observed values and changes from baseline in ECG interval measurements will be summarized by analysis visit. Clinically significant changes from baseline will be reported as adverse events
  • Incidence of TEAEs as measured by changes from baseline in vital signs measures [ Time Frame: Vital signs will be assessed from screening, until the end of subject participation (end of study or early termination visit as applicable), up to 45 days from the screening visit. ]
    Observed values and changes from baseline in vital signs (blood pressure, respiratory rate, heart rate and temperature) will be summarized by analysis visit. Clinically significant changes will be reported as adverse events.
  • Incidence of TEAEs as measured by physical examination changes [ Time Frame: Labs will be assessed from screening, until the end of subject participation (end of study or early termination visit as applicable) ]
    Clinically significant changes in physical examination findings will be reported as adverse events
  • Plasma pharmacokinetic (PK) parameters of single doses of INDV-2000 as measured by maximum concentration (Cmax) [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 72 hours post-dose ]
    Concentrations for INDV-2000 and its metabolite (M12) will be measured
  • Plasma PK parameters of single doses of INDV-2000 as measured by time to reach maximum plasma concentration (Tmax) [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 72 hours post-dose ]
    Concentrations for INDV-2000 and its metabolite (M12) will be measured
  • Plasma PK parameters of single doses of INDV-2000 as measured by area under the plasma concentration-time curve (AUC) [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 72 hours post-dose ]
    Concentrations for INDV-2000 and its metabolite (M12) will be measured
  • Plasma PK parameters of single doses of INDV-2000 as measured by plasma clearance [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 72 hours post-dose ]
    Concentrations for INDV-2000 and its metabolite (M12) will be measured
  • Plasma PK parameters of single doses of INDV-2000 as measured by plasma terminal half-life [ Time Frame: PK samples will be obtained at selected timepoints from pre-dose until 72 hours post-dose ]
    Concentrations for INDV-2000 and its metabolite (M12) will be measured
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE INDV-2000 First in Human
Official Title  ICMJE 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
Brief Summary This study will be a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD). 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Part I-sequential escalating doses will be administered Part II-study medication will be administered under fed and fasted conditions
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Opioid Dependence
Intervention  ICMJE
  • Drug: INDV-2000
    Study medication (active) will be administered as either powder in solution or powder in capsule, depending on dose administered.
    Other Name: C4X
  • Other: matching placebo
    Study medication (placebo) will be administered as either powder in solution or powder in capsule, depending on dose administered.
    Other Name: placebo
Study Arms  ICMJE
  • Experimental: Part I-Active arm
    Each cohort will be randomized to either placebo-matched or active INDV-2000 in increasing doses. In each cohort a sentinel group of 2 subjects will be randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort
    Intervention: Drug: INDV-2000
  • Placebo Comparator: Part II-Placebo arm
    Each cohort will be randomized to either placebo-matched or active INDV-2000 in increasing doses. In each cohort a sentinel group of 2 subjects will be randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort
    Intervention: Other: matching placebo
  • Experimental: Part II-Active arm-fed
    Study medication will be administered after a high fat meal. Dose to be determine based on a well-tolerated dose studied in Part I.
    Intervention: Drug: INDV-2000
  • Experimental: Part II-Active arm-fasting
    Study medication will be administered under fasted conditions. Dose to be determine based on a well-tolerated dose studied in Part I.
    Intervention: Drug: INDV-2000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2021)
72
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
56
Actual Study Completion Date  ICMJE April 12, 2021
Actual Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, be able to comply with protocol requirements, rules and regulations of 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 who is willing to consume a high-fat meal.
  • Body mass index (BMI) within 18.0 to 30.0 kg/m2, 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04413552
Other Study ID Numbers  ICMJE INDV-2000-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Indivior Inc.
Study Sponsor  ICMJE Indivior Inc.
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Martin Kankam altasciences
PRS Account Indivior Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP