Trials / Completed
CompletedNCT04413552
INDV-2000 First in Human
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Indivior Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INDV-2000 | INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered. |
| DRUG | Placebo | Placebo will be administered as either powder in solution or powder in capsule, depending on dose administered. |
Timeline
- Start date
- 2020-07-06
- Primary completion
- 2021-04-13
- Completion
- 2021-04-13
- First posted
- 2020-06-04
- Last updated
- 2024-05-16
- Results posted
- 2022-09-28
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04413552. Inclusion in this directory is not an endorsement.