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A Single-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Multiple-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-389949 in Healthy Subjects
This is a single-center, double-blind, parallel-group, randomized, placebo-controlled, multiple-ascending oral dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy subjects. Part A of the study will evaluate the safety and tolerability following once a day oral dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and pharmacodynamics. Part B of the study will evaluate the safety and tolerability of ACT-389949 following a maximum of two different oral dosing regimens: ACT-389949 given either every 3 days for 13 days or every 2 days for 9 days (5 doses for each regimen). Part C of the study, if required, will provide additional information to that obtained from Parts A and B in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949.
Details
| Lead sponsor | Idorsia Pharmaceuticals Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 65 |
| Start date | 2012-11 |
| Completion | 2013-05 |
Conditions
- Healthy Subjects
Interventions
- ACT-389949 40 mg
- ACT-389949 200 mg
- ACT-389949 800 mg
- ACT-389949 (Group C1 dose to be selected)
- ACT-389949 (Group C2 dose to be selected)
- Placebo
Primary outcomes
- Change from baseline up to end of study in supine systolic blood pressure — Up to 13 days
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 end of study in supine diastolic blood pressure — Up to 13 days
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 end of study in pulse rate — Up to 13 days
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 end of study in body temperature — Up to 13 days
Body temperature will be measured in the ear, where possible using the same thermometer(s) for all the subjects throughout the study. - Change from baseline up to end of study in body weight — Up to 13 days
Body weight will be measured where possible using the same weighing scale for all subjects throughout the study. The weighing scale should have a precision of at least 0.5 kg. - Change from baseline up to end of study in PQ/PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) — Up to 13 days
PQ/PR interval will be determined from standard 12-lead electrocardiogram (ECG) recorded in the supine position, after a 5-minute period of resting.
Countries
United Kingdom