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NCT01798979 · ClinicalTrials.gov registry record · Phase 1
A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects
A Phase 1 study of Healthy, sponsored by Galapagos.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01798979: Completed Phase 1 study of Healthy, sponsored by Galapagos.
NCT01798979 is a Phase 1 study of Healthy that has completed, run by Galapagos. The registered enrollment target is 20 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01798979, a Phase 1 study of Healthy, has completed, sponsored by Galapagos.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days). Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.
Primary Outcome
To characterize the amount of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG0634 - pharmacokinetics (PK) - in healthy subjects
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG GLPG0634
Study Locations (1)
Wisconsin
- Covance Clinical Research Unit - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01798979 record still lists
NCT01798979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT01798979 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT01798979 about?
NCT01798979 is a clinical study titled "A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects". This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before ...
What is the current status of trial NCT01798979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-02. Estimated completion is 2013-04.
What conditions does trial NCT01798979 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT01798979?
The interventions under investigation include: Midazolam (DRUG), GLPG0634 (DRUG).
Who is sponsoring clinical trial NCT01798979?
This trial is sponsored by Galapagos, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01798979 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01798979's enrollment target sits among peer trials
20 861st of 1090 higher than 194 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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