Study Assessing Pharmacokinetics and Bioavailability of Three Novel Triazine Compounds

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 10, 2018

Primary Completion Date

November 3, 2018

Study Completion Date

November 3, 2018

Conditions
Malaria
Interventions
DRUG

WR826647

100 mcg Carbon-14 radio labeled WR826647 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.

DRUG

WR909388

100 mcg Carbon-14 radio labeled WR909388 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.

DRUG

WR909390

100 mcg Carbon-14 radio labeled WR909309 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.

Trial Locations (1)

68502

Celerion, Lincoln

All Listed Sponsors
collaborator

Walter Reed Army Institute of Research (WRAIR)

FED

lead

U.S. Army Medical Research and Development Command

FED

NCT03436160 - Study Assessing Pharmacokinetics and Bioavailability of Three Novel Triazine Compounds | Biotech Hunter | Biotech Hunter