Healthy Subjects
Conditions
Brief summary
A study in healthy male subjects to investigate whether administration of rifampicin can affect the fate in the body (amount and time of presence in the blood) of clazosentan
Interventions
DRUGClazosentan
Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h
DRUGRifampicin
Single i.v. dose of 600 mg rifampicin for 30 min
Single i.v infusion of 500 mL saline for 30 min
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized, double-blind, two-period, cross-over Phase 1 study
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure. * Healthy male subjects aged between 18 and 65 years (inclusive) at Screening. * Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening. * Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period. * Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests. Study-specific criteria \- Acceptance for the duration of the study and for 3 months thereafter to use a condom and not to procreate.
Exclusion criteria
* Previous exposure to clazosentan. * Previous exposure to rifampicin within 3 months prior to Screening. * Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients. * Known hypersensitivity or allergy to natural rubber latex. * Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening. * History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening. * Positive results for hepatitis B surface antigen or hepatitis C virus antibody at Screening. * Positive results from the HIV serology at Screening. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC from zero to time t of the last measured concentration above the limit of quantification | 24 hours post treatment infusion initiation | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| AUC from zero to infinity (AUC0-inf) | 24 hours post treatment infusion initiation | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| AUC from zero to 3 h (AUC0-3) | 24 hours post treatment infusion initiation | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| The maximum plasma concentration (Cmax) | 24 hours post treatment infusion initiation | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Terminal half-life (t½) | 24 hours post treatment infusion initiation | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Total body clearance (CL) | 24 hours post treatment infusion initiation | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Volume of distribution at steady state (Vss) | 24 hours post treatment infusion initiation | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles |
Countries
Netherlands
Outcome results
None listed