Single center, open label, non-randomized, non-placebo controlled study to investigate the pharmacokinetics, metabolic disposition, and mass balance after single administration of 20 mg [14C]neladenoson bialanate (oral solution) in healthy male subjects.

Single center, open label, non-randomized, non-placebo controlled study to investigate the pharmacokinetics, metabolic disposition, and mass balance after single administration of 20 mg [14C]neladenoson bialanate (oral solution) in healthy male subjects. - Neladenoson bialanate mass balance study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44620

Enrollment

Registered

2017-10-15

Start date

2017-06-06

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

heart failure

Interventions

Not applicable.

Chronic heart failure.

Neladenoson bialanate.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects light skin (Caucasian) 18 - 55 years of age, inclusive BMI 18.0 - 29.9 kilograms/meter2 smoking less than 10 cigarettes per day

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
Measure the cumulative amount (as well as the time course) of drug-related, radioactive-labeled material excreted in urine and feces following a single oral dose of 20 mg neladenoson bialanate blended with radiolabeled [14C]neladenoson bialanate.	—

Secondary

Measure	Time frame
Assess the safety and tolerability of 20 mg neladenoson bialanate administered as an oral solution in healthy male subjects.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)