Sarcoma MedDRA version: 14.0 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: LLT Classification code 10006008 Term: Bone sarcoma NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy, male subjects, aged 18 to 45 years. 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 21 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the whole blood pharmacokinetics and comparative bioavailability (AUC0-8, Cmax, Tmax and apparent t1/2) of 2 new granule formulations of ridaforolimus compared to the provisional market 10 mg ECT in healthy subjects.;Secondary Objective: To compare the whole blood pharmacokinetic data (AUC0-8, Cmax, Tmax, and apparent t½) following single 40 mg ridaforolimus enteric coated and uncoated granules administration in the fed state with a high-fat breakfast and fasted states in healthy young male subjects.;Primary end point(s): AUC, Cmax, Tmax, apparent t1/2 of all formulations of ridaforolimus.;Timepoint(s) of evaluation of this end point: Predose (0), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 168 hours postdose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): AUC, Cmax, Tmax, apparent t1/2 of all formulations of ridaforolimus in the fed and fasted states.;Timepoint(s) of evaluation of this end point: Predose (0), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 168 hours postdose. | — |
Countries
United States
Contacts
Public ContactGlobal Clinical Trial Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed