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

Phase 1

Completed

• Conditions: Endometriosis
• Interventions: Drug: Placebo; Drug: BAY2328065

• Registration Number: NCT03427788
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-09
• Study Start: 2018-03-21
• Primary Completion: 2018-10-29
• Study Completion: 2019-02-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 72

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Study group 1-11 of Placebo
Verum	BAY2328065	Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)

Primary Outcome Measures

Name	Time	Method
Severity of treatment-emergent adverse events	Up to 8 days	The severity of adverse events collected from dosing until follow up, i.e. 8 days after dosing; Severity is assessed by the following criteria: 1. Results in death; 2. Is life-threatening; 3. Requires inpatient hospitalization or prolongation of existing hospitalization; 4. Results in persistent or significant disability / incapacity; 5. Is a congenital anomaly / birth defect; 6. Is another serious or important medical event as judged by the investigator
Incidence of treatment-emergent adverse events	Up to 8 days	The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing

Trial Locations

Locations (1)

CRS Clinical Research Services Berlin GmbH; 🇩🇪 Berlin, Germany