Parexel
Berlin, 14050, Germany
NCT Number: NCT03165097
The primary purpose of this study is to evaluate the safety and tolerability of ascending multiple doses of ACT-709478 in healthy male and female subjects
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Berlin, 14050, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hard gelatine capsules for oral administration
Placebo capsules matching ACT-709478 capsules
Midazolam oral solution (2 mg/mL) applied with a syringe
Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe
Time frame: up to Day 23
The percentage of subjects with treatment-emergent adverse events will be reported
Time frame: up to Day 23
Vital signs include diastolic and systolic blood pressure and pulse rate
Time frame: up to Day 23
The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported
Time frame: up to Day 23
Cmax is derived from the observed plasma concentration-time curves
Time frame: up to Day 23
tmax is directly derived from the observed plasma concentrations
Time frame: up to Day 23
t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves
Time frame: up to Day 23
AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval
Time frame: 24 hours after dosing on Day 1, Day 22 and Day 30
AUCtau is defined as the area under the plasma concentration-time curve during one dosing interval
Time frame: 24 hours after dosing on Day 1, Day 22 and Day 30
tmax is directly derived from the observed plasma concentrations
Time frame: 24 hours after dosing on Day 1, Day 22 and Day 30
Cmax is derived from the observed plasma concentration-time curves
Idorsia Pharmaceuticals Ltd.
Industry
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-709478 in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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