A single-center, open-label, single oral dose study to investigate the absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics of EMA401 after a single dose of [14C]EMA401 in healthy male subjects

A single-center, open-label, single oral dose study to investigate the absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetics of EMA401 after a single dose of [14C]EMA401 in healthy male subjects - EMA401 human ADME study in healthy male subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44485

Enrollment

Registered

2017-07-13

Start date

2017-07-27

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

neuralgia peripheral neuropathic pain

Interventions

The volunteer will receive a single dose of 100 mg radiolabeled EMA401 as an oral capsule.

ADME

EMA401

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - healthy male subjects - 40-55 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 60 days before the start of this study. Donation or loss of 50 mL or more of blood within eight weeks prior to initial dosing, or longer if required by local regulation.

Design outcomes

Primary

Measure	Time frame
- Excretion/ mass balance of [14C]-radioactivity in excreta (urine, feces) as percentage (% ) of administered dose - Cmax, Tmax, AUC, T1/2 and any other PK parameters as appropriate from the concentration vs. time data of 14C radioactivity (whole blood, plasma) - Cmax, Tmax, T1/2, AUC, CL/F, Vz/F any other pharmacokinetic parameter as appropriate from concentration vs. time profiles of EMA401 and known metabolites, if applicable.	—

Measure

Time frame

- Excretion/ mass balance of [14C]-radioactivity in excreta (urine, feces) as percentage (% ) of administered dose - Cmax, Tmax, AUC, T1/2 and any other PK parameters as appropriate from the concentration vs. time data of 14C radioactivity (whole blood, plasma) - Cmax, Tmax, T1/2, AUC, CL/F, Vz/F any other pharmacokinetic parameter as appropriate from concentration vs. time profiles of EMA401 and known metabolites, if applicable.

—

Secondary

Measure	Time frame
All safety and tolerability data (including vital signs, ECG parameters, clinical safety laboratory parameters, averse events reporting, physical examination) up until and including 14 days post-dose	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)