NCT04655898

Metabolism and Excretion of [14C]CC-90001 in Healthy Male Subjects

Completed Phase 1 Last updated 25 June 2021

What this trial tests

Phase 1 trial testing [14C]CC-90001 in Healthy Volunteer in 8 participants. Completed in 11 March 2021.

Timeline

16 December 2020

Primary endpoint
11 March 2021

11 March 2021

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	16 December 2020
Primary completion	11 March 2021
Estimated completion	11 March 2021
Sites	1 location across United States

Drugs / interventions tested

• [14C]CC-90001 — full drug profile →

Conditions studied

• Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 55, male only, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a clinical pharmacology study to characterize the biotransformation and excretion of \[14C\]CC-90001 and to evaluate the safety and tolerability of \[14C\]CC-90001 following a single oral dose of \[14C\]CC-90001 in healthy male subjects. Approximately 8 subjects will be enrolled into the study with a goal of 6 subjects being eligible for analysis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-kinase targeting of oncogenic c-Jun N-terminal kinase (JNK) signaling: the future of clinically viable cancer treatments.
   Latham SL, O'Donnell YEI, O'Donnell YEI, Croucher DR. · · 2022 · cited 13× · PMID 36454622 · DOI 10.1042/bst20220808