NCT02828930View on ClinicalTrials.gov

A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies)

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

September 8, 2016

Primary Completion Date

June 19, 2017

Study Completion Date

June 19, 2017

Conditions
Solid Tumors
Interventions
DRUG

Idasanutlin

Idasanutlin 300 mg tablet orally on Day 1; 400 mg tablet orally on Day 11 and Day 19. Participants, who are eligible to enter in optional treatment extension phase, will continue treatment with idasanutlin 200 mg tablet orally once daily for 5 days of 28-day cycle.

DRUG

Placebo

Placebo matching to idasanutlin aqueous dispersion will be administered orally on Day 11.

DRUG

[13C]-radiolabeled Idasanutlin

\[13C\]-radiolabeled idasanutlin 100 mcg will be administered as IV infusion over 15-minute on Day 1.

DRUG

[14C]-radiolabeled Idasanutlin

\[14C\]-radiolabeled idasanutlin 100 mg capsule (2, 50 mg capsules containing approximately 100 microcurie of radioactivity) will be administered orally on Day 1.

Trial Locations (1)

H-1134

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02828930 - A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies) | Biotech Hunter | Biotech Hunter