PHARMACOKINETICS AND METABOLISM OF 14C-LABELED GRC 4039 SODIUM FOLLOWING A SINGLE ORAL ADMINISTRATION IN HEALTHY MALE VOLUNTEERS

PHARMACOKINETICS AND METABOLISM OF 14C-LABELED GRC 4039 SODIUM FOLLOWING A SINGLE ORAL ADMINISTRATION IN HEALTHY MALE VOLUNTEERS - 14C-LABELED GRC 4039 SODIUM STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37911

Enrollment

Registered

2012-01-03

Start date

2012-01-24

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

chronische ontstekingsziekten chronic inflammatory disorders

Interventions

A single oral dose of 30 mg GRC 4039 sodium, containing appromxiately 3.7 MBq radiocarbon on Day 1.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male subjects 18-55 yrs, inclusive BMI: 18.5-29.5 kg/m2, inclusive Weight: 55-95 kg, inclusive 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
Pharmacokinetics: Pharmacokinetic parameters, based on the plasma and urine concentrations of total radioactivity, parent GRC 4039 and metabolite GRC 4037, the fecal radioactivity concentrations and metabolite profiling Safety: AEs, vital signs, 12-lead ECG; clinical laboratory, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)