BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect

Bayer

Status and phase: Completed; Phase 1

Conditions: Clinical Trials, Phase I as Topic

Treatments: Drug: BAY1902607; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03212586

18922

2017-000978-11 (EudraCT Number)

Details and patient eligibility

About

This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated

Enrollment: 72 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects.
• Age: 18 to 45 years (inclusive) .
• Body mass index (BMI) : ≥18 and ≤30 kg/m^2.
• Race: White.

Exclusion criteria

• Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
• Relevant diseases within the 4 weeks before the first drug administration.
• Febrile illness within the week before the first taste test is conducted.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Dose escalation BAY1902607

Experimental group

Description:

Dose 1 to 9 of BAY1902607

Treatment:

Drug: BAY1902607

Dose escalation Placebo

Placebo Comparator group

Description:

Dose 1 to 9 of matching placebo

Treatment:

Drug: Placebo