Status:
COMPLETED
Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers
Lead Sponsor:
Bayer
Collaborating Sponsors:
Orion Corporation, Orion Pharma
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
45-65 years
Phase:
PHASE1
Brief Summary
Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and Pgp substrate
Eligibility Criteria
Inclusion
- Healthy subject - as determined by the investigator or medically qualified designee based on medical evaluations including medical history, physical examination, laboratory tests and cardiac monitoring.
- Gender: Male.
- Age: 45 to 65 years (inclusive) at the screening visit.
- Race: White.
- Body mass index (BMI): ≥18.0 and ≤30.0 kg/m2.
- Agree to use condoms as an effective contraception barrier method and refrain from sperm donation during the whole study (starting after informed consent) and for 3 months after the end of treatment with darolutamide.
- In addition, participants must agree to utilize a second reliable method of contraception simultaneously. The second method which has to be used by a female partner of childbearing potential can be one of the following methods: diaphragm or cervical cap with spermicide or intra-uterine device or hormone-based contraception. Therefore, contraception methods to be used by male subjects and female partners are in line with clinical trial facilitation group recommendations related to contraception in clinical trials.
- Ability to understand and follow study-related instructions.
- Results of alcohol tests are negative at screening and on Study Day -1.
- Confirmation of the subject's health insurance coverage prior to the first screening examination/visit.
Exclusion
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (for example seizures) or other organs (e.g. diabetes mellitus).
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal.
- Known history of hypersensitivity (or known allergic reaction) to medications including any ingredient of midazolam, benzodiazepines, dabigatran etexilate, or darolutamide.
- Relevant hepatic disorders like cholestasis, disturbances of bilirubin metabolism, any progressive liver disease.
- Relevant renal disorders like recurrent glomerulonephritis, renal injury, and renal insufficiency. However, a history of a single episode of uncomplicated nephrolithiasis will not prevent participation.
- CYP3A4 inhibitors within 1 week or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.
- CYP3A4 inducers as well as St John's Wort within 28 days or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.
- Known BCRP and OATP substrates within 28 days or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.
- P-gp inducers (e.g. rifampin) within 28 days or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.
- P-gp inhibitors within 1 week or 5 drug half-lives, whichever is longer, before start of study treatment or during the study.
Key Trial Info
Start Date :
August 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03237416
Start Date
August 2 2017
End Date
December 18 2017
Last Update
November 6 2018
Active Locations (1)
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1
CRS Clinical-Research-Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167