A Phase 1 interventional study of ACT-709478 and ACT-709478 in Healthy Subjects, sponsored by Idorsia Pharmaceuticals Ltd.. Completed at 1 site in Czechia. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Idorsia Pharmaceuticals Ltd. · Phase 1, Interventional, and Other
This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the pharmacokinetics of 2 different formulations of ACT-709478 in healthy male participants. The participants will be treated in a crossover design with 2 different treatment periods. Pharmacokinetics (PK) is the study of the absorption and breakdown of the study drug in the body.
The duration of participation in this study is approximately 8 weeks from screening to the end of study visit. A screening visit is required within 21 to 3 days prior to the start of the study to determine whether the participant qualifies and is willing to enter in this research study. This study requires the participant to have two in-patient stays in the research clinic. Each in-patient stay is planned for 5 days (4 nights). Eleven days after each dose the participant will have an examination. There will be an in-between period (i.e., time between the end of period 1 and study treatment administration in Period 2) of 7 to 14 days. A safety follow-up telephone call for all participants who have received at least one study treatment will take place 30 to 40 days after the end of study examination or study discontinuation.
Idorsia Pharmaceuticals Ltd. is the lead sponsor of 102 studies on the registry; 5 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 9 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Test drug 60 mg single dose
Drug: ACT-709478
60 mg single dose
Drug: ACT-709478
1 film-coated minitablet contains 2 mg of ACT-709478
1 hard capsule contains 10 mg of ACT-709478.
The area under the plasma concentration-time curve (AUC 0-t).
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
The area under the plasma concentration-time curve (AUC 0-inf)
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
The maximum plasma concentration (Cmax)
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
The time to reach Cmax (tmax)
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
The terminal elimination half-life (t1/2)
Time frame: Multiple time points; duration for up to 264 hours in each treatment period.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Idorsia Pharmaceuticals Ltd.