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

NCT03427788 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-02-29

No results posted yet for this study

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

Interventions

DRUG

BAY2328065

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

DRUG

Placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-21
Primary Completion
2018-10-29
Completion
2019-02-11

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03427788 on ClinicalTrials.gov