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BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

Bayer logo

Bayer

Status and phase

Completed
Phase 1

Conditions

Endometriosis

Treatments

Drug: Placebo
Drug: BAY2328065

Study type

Interventional

Funder types

Industry

Identifiers

NCT03427788
2017-004056-38 (EudraCT Number)
19250

Details and patient eligibility

About

This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065

Enrollment

72 patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male volunteers, aged 18 - 45 years
  • Body mass index (BMI): 18 ≤ BMI ≤ 30 kg/m²
  • Smoking less than 10 cigarettes / day
  • Signed informed consent
  • Use of an accepted method of contraception for the duration of the study.

Exclusion criteria

  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors
  • Known severe allergies, non allergic drug reactions, or multiple drug allergies
  • Medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters
  • Clinically relevant findings in physical examination; ECG, blood pressure; laboratory values

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups, including a placebo group

Verum
Experimental group
Description:
Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)
Treatment:
Drug: BAY2328065
Placebo
Placebo Comparator group
Description:
Study group 1-11 of Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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