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.

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. - CS0296 (ID-054-106)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45870

Enrollment

Registered

2018-06-15

Start date

2018-07-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebral vasospasm (cerebral hemorrhage)

Interventions

The study will start with a screening. At the screening a physical examination will take place and a few other standard medical assessments will be performed (ECG,vital signs). Furthermore a blood a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subjects aged between 18 and 65 years (inclusive) with a Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening. ;Further inclusion criteria can be found in the protocol section 3.2.2.

Exclusion criteria

Exclusion criteria: 1. Previous exposure to clazosentan. 2. Previous exposure to rifampicin within 3 months prior to Screening. 3. Known hypersensitivity to clazosentan or rifampicin or treatments of the same class, or any of their excipients. ;Further exclusion criteria can be found in the protocol section 3.2.3.

Design outcomes

Primary

Measure	Time frame
The pharmacokinetic parameters.	—

Secondary

Measure	Time frame
The safety endpoint parameters are frequency and severity of adverse events, vital signs, electrocardiography (ECG), safety laboratory tests and urinalysis.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)