4 completed, 1 terminated. 5 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 4, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users Pitolisant, Placebos, Phentermine - Healthy, Drug Abuse | Phase 1 | Completed | Bioprojet | 43 | 2017-03-15 | 2017-11-13 |
| Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers Pitolisant, [14C]-Pitolisant - Healthy Volunteers | Phase 1 | Completed | Bioprojet | 8 | 2016-07-01 | 2016-10-11 |
| First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 BP1.5375 suspension, Diphenhydramine, Placebo - Healthy Male Volunteers | Phase 1 | Terminated | Bioprojet | 48 | 2014-10-01 | 2015-01-21 |
| Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules Racecadotril suspension, Racecadotril granules - Healthy Male Volunteers | Phase 1 | Completed | Bioprojet | 53 | 2013-09-01 | 2014-02-25 |
| Pharmacokinetics of BF2.649 in Renal Impairment BF2.649 - Renal Impairment | Phase 1 | Completed | Bioprojet | 25 | 2011-07-01 | 2013-04-12 |
Renal Insufficiency (1) · Substance-Related Disorders (1)
pitolisant (3) · Diphenhydramine (1) · Phentermine (1)
France (2) · Canada (1) · Netherlands (1)
Litza McKenzie, MD (1) · Michael B. McDonnell, MD (1) · Thierry Duvauchelle, MD (1) · Yves Donazzolo, MD (1) · van Gerven Joop, MD (1)
2016 (1)