NCT02994381

A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults

A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Celgene · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This will be an open-label, non-randomized, single oral dose study in healthy male subjects. All subjects will receive a single oral dose of 10 mL of \[14C\]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.

Detailed description

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Subjects will be admitted to the clinical unit on the morning of Day -1 prior to IMP administration. Subjects will be dosed on the morning of Day 1 following a standard breakfast, and will remain resident in the clinic until up to 168 h after dosing. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. This may be earlier than 168 h post-dose but no sooner than 96 h post-dose. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criteria has not been met by all subjects on Day 8, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects. A follow-up phone call will take place 5 to 10 days after discharge.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RPC1063

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-12-15
• Last updated: 2017-01-27

Locations

1 site across 1 country: United Kingdom