Healthy Subjects Clinical Trial
Official title:
A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Clazosentan in Healthy Male Subjects
Verified date | October 2018 |
Source | Idorsia Pharmaceuticals Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 14 |
Est. completion date | August 3, 2018 |
Est. primary completion date | August 3, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | QPS Netherlands B.V. | Groningen |
Lead Sponsor | Collaborator |
---|---|
Idorsia Pharmaceuticals Ltd. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUC from zero to time t of the last measured concentration above the limit of quantification | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles | 24 hours post treatment infusion initiation | |
Primary | AUC from zero to infinity (AUC0-inf) | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles | 24 hours post treatment infusion initiation | |
Primary | AUC from zero to 3 h (AUC0-3) | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles | 24 hours post treatment infusion initiation | |
Primary | The maximum plasma concentration (Cmax) | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles | 24 hours post treatment infusion initiation | |
Primary | Terminal half-life (t½) | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles | 24 hours post treatment infusion initiation | |
Primary | Total body clearance (CL) | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles | 24 hours post treatment infusion initiation | |
Primary | Volume of distribution at steady state (Vss) | The plasma PK parameters of clazosentan will be derived by non-compartmental analysis of the plasma concentration-time profiles | 24 hours post treatment infusion initiation |
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