Evaluating the Safety and Plasma Levels of N-Methanocarbathymidine (N-MCT) in Normal Patients

PHASE1UnknownINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Toxicity
Interventions
DRUG

N-Methanocarbathymidine

Patients will receive 200 mg, 400 mg, 800 mg or 1200 mg of N-Methanocarbathymidine administered orally on day 1 after subject's full screen for each cohort. Each dose will be completely evaluated for safety and pharmacokinetics. The doses of each cohort will be given after complete evaluation of the preceding cohort for any sign of toxicity. In the absence of no observed toxicity, the next cohort will be started in the normal subjects.

OTHER

Placebo Capsule

Two patients in Cohort 3 \& 4 will receive placebo capsules which is mannitol filled into size 0 capsules.

Trial Locations (1)

20007

Georgetown University Hospital, Washington D.C.

Sponsors
All Listed Sponsors
lead

N&N Pharmaceuticals Inc.

INDUSTRY