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Mass Balance and Pharmacokinetics Study of Derazantinib in Healthy Male Subjects

NCT04098692 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-01-19

No results posted yet for this study

Summary

This is a Phase 1, two-part, open-label, single centre, single arm study in healthy male subjects to investigate the oral PK, intravenous (IV) PK, mass balance, bioavailability and metabolites profiling and identification of derazantinib.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Derazantinib capsule

300 mg derazantinib oral administration (3x100 mg capsules)

DRUG

[14C]-Derazantinib solution for infusion

100 μg \[14C\]-derazantinib intravenous administration

DRUG

[14C]-Derazantinib capsule

300 mg \[14C\]-derazantinib oral administration (3x100 mg capsules)

Sponsors & Collaborators

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Nand Singh, MD · Quotient Sciences

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2019-11-18
Completion
2019-11-18

Countries

  • United Kingdom

Study Locations

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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 NCT04098692 on ClinicalTrials.gov