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NCT01995383 · ClinicalTrials.gov registry record · Phase 1
A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT01995383 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 88 participants.
The verdict
NCT01995383, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteers. In Part 2, participants will be given two single oral doses of RO6836191 or placebo under low or normal-salt diet conditions. A subset of these participants will subsequently receive a single IV dose of RO6836191 for further analysis.
Interventions
- DRUG Placebo
- OTHER LS followed by NS diet condition
- OTHER NS followed by LS diet condition
- DRUG RO6836191
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2013-11 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01995383
The ClinicalTrials.gov registry entry for NCT01995383 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01995383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01995383 about?
NCT01995383 is a clinical study titled "A Single Ascending Dose Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of RO6836191 in Healthy Male Volunteers.". This single-center, randomized, placebo-controlled, double-blind study will assess the safety, pharmacokinetics and pharmacodynamics of RO6836191 in healthy male volunteers in two parts. Part 1 will assess the safety of oral single ascending doses of RO6836191 compared to placebo in fasted volunteer...
What is the current status of trial NCT01995383?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2013-11. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01995383?
The interventions under investigation include: Placebo (DRUG), LS followed by NS diet condition (OTHER), NS followed by LS diet condition (OTHER), RO6836191 (DRUG).
Who is sponsoring clinical trial NCT01995383?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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