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

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