AN OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS OF ASP7035 AFTER A SINGLE ORAL DOSE OF 14C-LABELED ASP7035 IN HEALTHY MALE SUBJECTS

AN OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS OF ASP7035 AFTER A SINGLE ORAL DOSE OF 14C-LABELED ASP7035 IN HEALTHY MALE SUBJECTS - ASP7035 MB

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34187

Enrollment

Registered

2010-07-22

Start date

2010-08-02

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Excessive night-time urination

Interventions

Active substance: ASP7035 and [14C]-ASP7035

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male - 18 - 55 years of age, inclusive - BMI 18.5 - 30.0 kg/m2 - Non-smoker, or not more than 10 cigarettes for at least three months before drug administration

Exclusion criteria

Exclusion criteria: Suffering from: hepatitis B, 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 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 12 months prior the start of this study. Participation is also not permitted when participated in more than 3 other drug studies in the 10 months prior to the start of this study.

Design outcomes

Primary

Measure	Time frame
Radiokinetics Pharmacokinetics Safety Tolerability	—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)