Cancer/oncology MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: sitravatinib malate
Product Code: MGCD516
Pharmaceutical Form: Capsule
INN or Proposed INN: N/A
Current Sponsor code: MGCD516
Other descriptive name: SITRAVATINIB
Concentration unit: mg
Sponsors
Mirati Therapeutics, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: Cmax, tmax, kel, t1/2, AUC0-t, AUC0-inf, AUC0-168, CL/F, and Vz/F MGCD515 in urine: Aeurine, feurine, and CLR Total radioactivity in plasma and whole blood: Cmax, tmax, kel, t1/2, AUC0-t, AUC0-inf, AUC0-168, and whole blood/plasma ratio Total radioactivity excretion in urine and feces: Aeurine, feurine, Aefeces, fefeces, Aetotal, and fetotal | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • AEs • Clinical laboratory • Vital signs • ECG • Physical examination ;Timepoint(s) of evaluation of this end point: Throughout the study | — |
Countries
Netherlands
Contacts
Public ContactVanessa Tassell
Mirati Therapeutics, Inc.
Outcome results
None listed