Trials / Terminated
TerminatedNCT03139500
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and an Open-Label Study to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JNJ-61803534 | Participants will receive JNJ-61803534 tablets orally. |
| DRUG | Placebo | Participants will receive matching placebo. |
| DRUG | Midazolam | Participants will receive single oral dose of midazolam. |
Timeline
- Start date
- 2017-05-17
- Primary completion
- 2018-04-05
- Completion
- 2018-04-05
- First posted
- 2017-05-04
- Last updated
- 2018-07-20
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03139500. Inclusion in this directory is not an endorsement.