Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT04211272
The purpose of this study is to evaluate the effect of macitentan at steady state on the pharmacokinetic (PK) of a single dose of riociguat and sildenafil (Part A); and rosuvastatin (Part B) when co-administered to healthy male participants under fasted conditions.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Merksem, 2170, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Macitentan will be administrated as film-coated tablet in Part A and Part B.
Other names: JNJ-67896062-AAA
Sildenafil will be administrated as film-coated tablet in Part A.
Other names: Revatio
Riociguat will be administrated as film-coated tablet in Part A.
Other names: Adempas
Rosuvastatin will be administrated as film-coated tablet in Part B.
Other names: Crestor
Time frame: Up to 25 days
AUC(0-infinity) is defined as area under the plasma analyte concentration-time curve from time 0 to infinite time.
Time frame: Up to 25 days
Cmax is defined as the maximum observed plasma analyte concentration.
Time frame: Up to 25 days
AUC(0-infinity) is defined as area under the plasma analyte concentration-time curve from time 0 to infinite time.
Time frame: Up to 25 days
Cmax is defined as the maximum observed plasma analyte concentration.
Time frame: Up to 25 days
AUC(0-t) is defined as area under the plasma analyte concentration-time curve from time 0 to time t of the last measured concentration above the lower limit of quantification (LLOQ), calculated according to the linear trapezoidal rule, using the measured concentration-time values above the LLOQ.
Time frame: Up to 25 days
Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
Time frame: Up to 25 days
t1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration. It is associated with the terminal slope of the semilogarithmic drug concentration-time curve, calculated as t1/2=0.693/ lambda(z).
Time frame: Up to 25 days
Ctrough is defined as the observed plasma concentration before dosing or at the end of the dosing interval.
Time frame: Up to Day 45
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Actelion
Industry
A Single-center, Open-label, Single-sequence, 2-part Study to Investigate the Effect of 75 mg Macitentan Once Daily at Steady State on the Pharmacokinetics of Riociguat, Sildenafil, Rosuvastatin and Tadalafil in Healthy Male 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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