At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 73 enrolled
Drug / intervention
INDV-2000 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating INDV-2000 and Placebo for Opioid Dependence. Completed, enrolled 73 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartJul 2020
Primary CompletionApr 2021
TodayJul 2026
First PostedJun 4, 2020
Enrollment StartJul 6, 2020
Primary CompletionApr 13, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.1 years ago
Interventions
INDV-2000drug
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.