A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of QBW251 following a single oral dose of [14C]QBW251 in healthy male subjects at steady state conditions.

A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of QBW251 following a single oral dose of [14C]QBW251 in healthy male subjects at steady state conditions. - QBW251 human ADME study at steady state in healthy male subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46062

Enrollment

Registered

2018-10-09

Start date

2018-11-07

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Longaandoeningen COPD lung diseases

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18 - 55 years of age weight at least 55 kilograms, and no more than 120 kg (BMI) 18 - 30 kilograms/meter2 non-smoking

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
To determine the rates and routes of excretion of [14C]QBW251 related radioactivity, including mass balance of total drug-related radioactivity in urine and feces following a single 400 mg oral dose of [14C]QBW251 at steady state in healthy volunteers. To determine the pharmacokinetics of total radioactivity in blood and plasma. To characterize the plasma pharmacokinetics of QBW251 and known key metabolites, if applicable.	—

Measure

Time frame

To determine the rates and routes of excretion of [14C]QBW251 related radioactivity, including mass balance of total drug-related radioactivity in urine and feces following a single 400 mg oral dose of [14C]QBW251 at steady state in healthy volunteers. To determine the pharmacokinetics of total radioactivity in blood and plasma. To characterize the plasma pharmacokinetics of QBW251 and known key metabolites, if applicable.

—

Secondary

Measure	Time frame
To assess the safety and tolerability of multiple oral doses of 400 mg of QBW251 administered to healthy male subjects	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)