A study in healthy male volunteers to investigate the absorption, metabolism and excretion of an oral dose of MGCD516 (sitravatinib) labeled with radiocarbon (14C). MGCD516 is a new compound being developed for the treatment of cancer. Radiocarbon labeling is used to follow the compound in the body.

Phase 1

• Conditions: Cancer/oncology; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003898-26-NL
• Lead Sponsor: Mirati Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

1. Gender: male.
2. Age: 18 to 55 years, inclusive, at screening.
3. Body mass index (BMI):18.0 to 30.0 kg/m2.
4. Weight: >50 kg.
5. Status: healthy subjects.
Further criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Employee of PRA or the Sponsor.
2. Significant history or clinical manifestation of any major system disorder, as determined by the Investigator (or designee).
3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
5. Presence of any other condition, including surgery, known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
Further criteria apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the absorption, metabolism, and excretion (AME), and mass balance of a single oral dose of 120 mg MGCD516 malate salt (therapeutic dose) containing XX MBq of [14C]-labeled MGCD516 in healthy male subjects;Secondary Objective: To evaluate the safety and tolerability of MGCD516 following a single oral dose of 120 mg MGCD516 malate salt;Timepoint(s) of evaluation of this end point: Throughout the study;Primary end point(s): MGCD515 in plasma:<br>Cmax, tmax, kel, t1/2, AUC0-t, AUC0-inf, AUC0-168, CL/F, and Vz/F <br><br>MGCD515 in urine:<br>Aeurine, feurine, and CLR<br><br>Total radioactivity in plasma and whole blood:<br>Cmax, tmax, kel, t1/2, AUC0-t, AUC0-inf, AUC0-168, and whole blood/plasma ratio <br><br>Total radioactivity excretion in urine and feces:<br>Aeurine, feurine, Aefeces, fefeces, Aetotal, and fetotal<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • AEs<br>• Clinical laboratory<br>• Vital signs<br>• ECG<br>• Physical examination<br>;Timepoint(s) of evaluation of this end point: Throughout the study