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

• ClinicalTrials.gov Identifier: NCT03427788
• Recruitment Status: Completed
• First Posted: February 9, 2018
• Last Update Posted: February 20, 2019
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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

Condition or disease	Intervention/treatment	Phase
Endometriosis	Drug: BAY2328065; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY2328065 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY2328065 in Healthy Men
• Actual Study Start Date: March 21, 2018
• Actual Primary Completion Date: October 29, 2018
• Actual Study Completion Date: February 11, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Verum; Study group 1-11 of BAY2328065 (increasing dose levels for study group 2-11)	Drug: BAY2328065; Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets
Placebo Comparator: Placebo; Study group 1-11 of Placebo	Drug: Placebo; Matching placebo, once daily in an escalating manner as LSF or tablets

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment-emergent adverse events [ Time Frame: Up to 8 days ]
   The frequency of adverse events collected from dosing until follow up, i.e. 8 days after dosing
2. Severity of treatment-emergent adverse events [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Germany

CRS Clinical Research Services Berlin GmbH

Berlin, Germany, 13353

Sponsors and Collaborators

Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03427788
• Other Study ID Numbers: 19250; 2017-004056-38 ( EudraCT Number )
• First Posted: February 9, 2018
• Last Update Posted: February 20, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Endometriosis