An open label, single dose, single period study to assess the mass balance recovery, metabolite profile and metabolite identification of [14C] APD421 administered via the intravenous route to healthy male subjects

An open label, single dose, single period study to assess the mass balance recovery, metabolite profile and metabolite identification of [14C] APD421 administered via the intravenous route to healthy male subjects - ADP421 Human ADME Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42878

Enrollment

Registered

2016-07-11

Start date

2016-07-13

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

misselijkheid en braken nausea vomiting

Interventions

The volunteer will receive a single dose of 10 mg radiolabeled APD421 as an intravenous infusion (in a vein) during 4 minutes (with a possible extension up to 8 minutes).

ADME

Amisulpride

APD412

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18-65 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 3 months before the start of this study or being a blood donor within 3 months from the start of the study. In case of donating more than 100 ml of blood in the 3 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
- To assess the mass balance recovery after a single IV dose of [14C]-APD421 - To identify the chemical structure of each metabolite accounting for * 10% of parent compound exposure - To determine the routes and rates of elimination of [14C]-APD421	—

Secondary

Measure	Time frame
- To further explore the IV PK of [14C]-APD421 - To evaluate the extent of distribution of total radioactivity into blood cells - To provide additional safety and tolerability information for APD421	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)