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Single-center, Double-blind, Randomized, Placebo-controlled, Single-ascending Dose and Food Interaction Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949 in Healthy Male Subjects
This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending single oral dose and food interaction Phase 1 study. It will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of ACT-389949 in healthy male subjects. It will also investigate the effect of food on the pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.
Details
| Lead sponsor | Idorsia Pharmaceuticals Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 65 |
| Start date | 2011-11 |
| Completion | 2012-05 |
Conditions
- Healthy Subjects
Interventions
- ACT-389949 1 mg
- ACT-389949 5 mg
- ACT-389949 20 mg
- ACT-389949 50 mg
- ACT-389949 100 mg
- ACT-389949 200 mg
- ACT-389949 500 mg
- ACT-389949 1000 mg
- Placebo
Primary outcomes
- Change from baseline up to 60 hours in supine systolic blood pressure — 60 hours
Blood pressure will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand) - Change from baseline up to 60 hours in standing systolic blood pressure — 60 hours
Blood pressure will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand) - Change from baseline up to 60 hours in supine diastolic blood pressure — 60 hours
Blood pressure will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand) - Change from baseline up to 60 hours in standing diastolic blood pressure — 60 hours
Blood pressure will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand) - Change from baseline up to 60 hours in pulse rate — 60 hours
Pulse rate will be measured using an automatic oscillometric device, always on the dominant arm (i.e., dominant arm right = writing with right hand) - Change from baseline up to 60 hours in body temperature — 60 hours
Body temperature will be measured in the sitting position using the same thermometer(s) for all the subjects and throughout the study.
Countries
Netherlands