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

NCT03427788 | Completed Phase 1

• 2 other identifiers: 192502017-004056-38
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events

  The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing

  Up to 8 days

• Severity of treatment-emergent adverse events

  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

  Up to 8 days

Study Arms (2)

Verum

EXPERIMENTAL

Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)

Drug: BAY2328065

Placebo

PLACEBO COMPARATOR

Study group 1-11 of Placebo

Drug: Placebo

Interventions

BAY2328065 DRUG

Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets

Verum

Placebo DRUG

Matching placebo, once daily in an escalating manner as LSF or tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

CRS Clinical Research Services Berlin GmbH

Berlin, 13353, Germany

Location

Related Links

• Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 9, 2018
• Study Start: March 21, 2018
• Primary Completion: October 29, 2018
• Study Completion: February 11, 2019
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

DE (1)