MedTrace Logo

A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males

NCT04804059 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-05-17

No results posted yet for this study

Summary

This is a single-center, open-label, non-randomized, single dose study in healthy male subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the target of achieving data in 4 evaluable subjects per cohort. Five subjects were to receive a single oral dose of APX001 and not more than (NMT) 3.1 megabecquerel (MBq) (84.0 microcurie \[μCi\]) 14C in the fed state. Five subjects were to receive a single IV administration containing APX001 and NMT 3.4 MBq (93.0 μCi) 14C in the fed state.

Conditions

Interventions

DRUG

[14C]-APX001 Oral Solution

Total dose containing NMT 3.1 MBq (84.0 µCi) 14C

DRUG

[14C]-APX001 Solution for Infusion

Total dose containing NMT 3.4 MBq (93.0 µCi) 14C

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Marc Engelhardt · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-17
Primary Completion
2018-09-26
Completion
2018-09-26
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04804059 on ClinicalTrials.gov