NCT02671097

Brief Summary

Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics. PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2016

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

January 29, 2016

Last Update Submit

September 7, 2016

Conditions

Healthy VolunteersPharmacokineticsDrug Interaction

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time curve of Rosuvastatin from time zero to 24 hours (AUC(0-24))

    Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration

  • Maximum drug concentration (Cmax) in plasma of Rosuvastatin

    Before Rosuvastatin administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after Rosuvastatin administration

Secondary Outcomes (4)

  • Number of subjects with study drug-related treatment-emergent Adverse Events

    Up to 30 days

  • Area under the concentration-time curve of BAY1841788 from time zero to 24 hours (AUC(0-24)) after single administration

    Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration, period 2 day 1

  • Area under the concentration-time curve of BAY1841788 from time zero to 12 hours (AUC(0-12)) after repeated administration

    Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 h after BAY1841788 administration, period 2 day 7

  • Maximum drug concentration (Cmax) in plasma of BAY1841788

    Before BAY1841788 administration, as well as 30 min, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 h after BAY1841788 administration

Study Arms (1)

BAY1841788 (ODM-201) + Rosuvastatin

EXPERIMENTAL

All subjects will receive a single dose BAY1841788 (ODM-201) (600 mg) followed by multiple doses BAY1841788 (ODM-201) (600 mg BID) as well as 2 times a single dose rosuvastatin (5 mg), once alone and once in combination with BAY1841788 (ODM-201).

Drug: RosuvastatinDrug: BAY1841788 (ODM-201)

Interventions

RosuvastatinDRUG

5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.

BAY1841788 (ODM-201) + Rosuvastatin
BAY1841788 (ODM-201)DRUG

600 mg single dose, administered as 2 x 300 mg tablets on Day 01 in Period 2; 600 mg BID multiple dose, administered as 2 x 300 mg tablets on Day 04 to Day 08 in Period 2.

BAY1841788 (ODM-201) + Rosuvastatin

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subject - as determined by medical history, physical examination and all procedures required by this protocol.
  • Age: 45 to 65 years at the screening visit.
  • Race: White.
  • Body mass index (BMI): ≥18.0 and ≤29.9 kg/m\*2.
  • Adequate venous access (frequent blood sampling).
  • Ability to understand and follow study-related instructions.
  • Females have to be in postmenopausal state, revealed by: Medical history, if applicable (natural menopause at least 12 months prior to first study drug administration; or surgical menopause by bilateral ovariectomy at least 3 months prior to first study drugadministration) and follicle stimulating hormone (FSH) \>40 IU/L at screening examination.
  • Male subjects must agree to use condoms as an effective contraception barrier method during the whole study (starting after informed consent) and for 3 months after the end of treatment with BAY1841788 (ODM-201). 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.

You may not qualify if:

  • Medical and surgical history
  • Subjects with clinically relevant findings in medical history e.g. history or currently existing relevant diseases of vital organs, 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.
  • Febrile illness within 1 week before the first study drug administration.
  • A medical history of risk factors for Torsades de Pointes (e.g. family history of Long QT interval in electrocardiogram Syndrome) or other arrhythmias.
  • History of myopathia after treatment with statins.
  • History of rhabdomyolysis or myopathia.
  • Medical history of any type of psychiatric disorder, especially mood disorders including medical history with suicidal ideation and/or suicide attempts.
  • History of thyroid disorders, especially hypothyreosis.
  • History of respiratory disorder (excluding history of bronchitis or pneumonia).
  • History of myasthenia.
  • History of muscle pain or muscle ache, muscle soreness of unknown origin or on frequent occasions although an origin might have been found.
  • History of any clinically significant hypoglycemia or hyperglycemia.
  • Relevant hepatic disorders like a history of viral hepatitis, 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, State of Berlin, 13353, Germany

Location

Related Publications (1)

  • Zurth C, Nykanen P, Wilkinson G, Taavitsainen P, Vuorela A, Huang F, Reschke S, Koskinen M. Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment. Clin Pharmacokinet. 2022 Apr;61(4):565-575. doi: 10.1007/s40262-021-01078-y. Epub 2021 Dec 6.

    PMID: 34866168DERIVED

MeSH Terms

Interventions

Rosuvastatin Calciumdarolutamide

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 2, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations

DE(1)