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Completed

NCT Number: NCT03596294

A Study in Healthy Male Subjects to Investigate Whether Administration of Rifampicin Can Affect the Fate of Clazosentan in the Body of Clazosentan

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

QPS Netherlands B.V.

Groningen, 9713 GZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clazosentan

Drug

Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h

rifampicin

Drug

Single i.v. dose of 600 mg rifampicin for 30 min

Saline (0.9% Sodium Chloride)

Other

Single i.v infusion of 500 mL saline for 30 min

Primary outcomes

  1. AUC from zero to time t of the last measured concentration above the limit of quantification

    Time frame: 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

  2. AUC from zero to infinity (AUC0-inf)

    Time frame: 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

  3. AUC from zero to 3 h (AUC0-3)

    Time frame: 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

  4. The maximum plasma concentration (Cmax)

    Time frame: 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

  5. Terminal half-life (t½)

    Time frame: 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

  6. Total body clearance (CL)

    Time frame: 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

  7. Volume of distribution at steady state (Vss)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 23, 2018
Registry last updated
Oct 23, 2018

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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