Open label, partially randomized, cross-over study to determine the absolute bioavailability and pharmacokinetics of BAY 1817080 using a simultaneous anticipated therapeutic oral dose along with an i.v. [13C715N]-labeled microtracer and to investigate the relative bioavailability of two formulations given under different diets at 2 dose levels in healthy volunteers.

Open label, partially randomized, cross-over study to determine the absolute bioavailability and pharmacokinetics of BAY 1817080 using a simultaneous anticipated therapeutic oral dose along with an i.v. [13C715N]-labeled microtracer and to investigate the relative bioavailability of two formulations given under different diets at 2 dose levels in healthy volunteers. - A absolute and relative bioavailability of BAY 1817080 study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46143

Enrollment

Registered

2018-11-01

Start date

2018-11-13

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronische hoest. Cough

Interventions

Group 1: Period 1 Tablet Formulation B 25 mg (1 x 25-mg tablet)

fasted Group 1: Period 2 not applicable Group 1: Period 3 not applicable Group 2: Period 1 Tablet Formulation B 100 mg (1 x 100-mg tablet) + 0.1 mg iv microdose (15-minute infusion)

fasted Group 2: Period 2 Tablet Formulation A 100 mg (4 x 25-mg tablet)

moderate-fat, moderate-calorie breakfast Group 2: Period 3 Tablet Formulation B 100 mg (1 x 100-mg tablet)

high-fat, high-calorie breakfast Group 3: Period 1 Tablet Formulation B 400 mg (4 x 100-mg tablet)

fasted Group 3: Period 2 Tablet Formulation A 400 mg (2 x 150-mg tablet plus 4 x 25-mg tablet)

moderate fat, moderate calorie breakfast Group 3: Period 3 Tablet Formulation B 400 mg (4 x 100-mg tablet)

high-fat, high-calorie breakfast In Period 3 of Group 3, the planned dose is 400 mg for the Tablet Formulation B administered after a high-fat, high-calorie breakfast. However, this dose may be low

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male volunteers 18 - 55 years of age weight at least 45 kilograms BMI 18 - 30 kilograms/meter2

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
determine the absolute bioavailability and pharmacokinetics (PK) of BAY 1817080 using a simultaneous oral dose of 100 mg (Formulation B, fasted state) along with an i.v. [13C715N]-labeled microtracer determine the relative bioavailability of Formulation B administered in fasted state or with a high-fat, high-calorie meal (HF, HC) versus Formulation A administered with a moderate-fat, moderate-calorie meal (MF, MC) at two dose levels (100 and 400 mg)	—

Measure

Time frame

determine the absolute bioavailability and pharmacokinetics (PK) of BAY 1817080 using a simultaneous oral dose of 100 mg (Formulation B, fasted state) along with an i.v. [13C715N]-labeled microtracer determine the relative bioavailability of Formulation B administered in fasted state or with a high-fat, high-calorie meal (HF, HC) versus Formulation A administered with a moderate-fat, moderate-calorie meal (MF, MC) at two dose levels (100 and 400 mg)

—

Secondary

Measure	Time frame
investigate the effect of a high-fat, high-calorie meal (HF, HC) on the PK of BAY 1817080 after a single oral dose of Formulation B at two doses (100 and 400 mg) in comparison to the fasted state investigate the dose proportionality in BAY 1817080 PK after a single oral dose of Formulation B at 25, 100 and 400 mg in fasted state * investigate the safety and tolerability of BAY 1817080	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)