Trial Condition(s):
Prostatic Neoplasms
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
Bayer Identifier:
18860
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and Pgp substrate
Inclusion Criteria
- 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 Criteria
- 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.
Trial Summary
Enrollment Goal
15
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Nubeqa (Darolutamide, BAY1841788)
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
| Locations | |
|---|---|
Locations CRS Clinical-Research-Services Mannheim GmbH Mannheim, Germany, 68167 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A Phase I, non-randomized, open-label, fixed-sequence study to investigate the effect of darolutamide (ODM-201) on the pharmacokinetics of a probe substrate of CYP3A4 and P-gp in healthy male volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- AUC in plasma of non-conjugated dabigatran (AUC(0-tlast), if AUC cannot be calculated)Exposure of non-conjugated dabigatran in plasma following a single administration of dabigatran etexilate AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose AUC(0-tlast): AUC from time 0 to the last data point > LLOQTimeframe: Period 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
- C(max) in plasma of non-conjugated dabigatranMaximum plasma concentration of non-conjugated dabigatran in plasma following a single administration of dabigatran etexilate Cmax: maximum observed drug concentration in measured matrix after single dose administrationTimeframe: Period 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
- AUC in plasma of midazolam (AUC(0-tlast), if AUC cannot be calculated)Exposure of midazolam in plasma following a single administration of midazolamTimeframe: PPeriod 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
- C(max) in plasma of midazolamMaximum plasma concentration of midazolam in plasma following a single administration of midazolamTimeframe: Period 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
Secondary Outcome
- Number of subjects with study drug-related treatment-emergent Adverse Event (TEAE)Timeframe: 30 days following last intake of Investigational Product
- AUC in plasma of total dabigatran (AUC(0-tlast), if AUC cannot be calculated)Exposure of total dabigatran in plasma following a single administration of dabigatran etexilateTimeframe: Period 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
- C(max) in plasma of total dabigatranMaximum plasma concentration of total dabigatran in plasma following a single administration of dabigatran etexilateTimeframe: Period 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
- AUC in plasma of 1-OH midazolam (AUC(0-tlast), if AUC cannot be calculated)Exposure of 1-OH midazolam in plasma following a single administration of midazolamTimeframe: Period 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
- C(max) in plasma of 1-OH midazolamMaximum plasma concentration of 1-OH midazolam in plasma following a single administration of midazolamTimeframe: PPeriod 1, Day 1: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing Period 2, Day 3 and 9: Predose, and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 72 hours post dosing
Additional Information
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