Conditions: Healthy
Keywords: Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 45
Healthy volunteers: yes

Brief summary:
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).

Detailed description:
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.

Arms:
arm 1: placebo capsule arm 2: 50 mg PG 760564 active arm 3: 100 mg PG 760564 active arm 4: 200 mg PG 760564 active arm 5: 400 mg PG 760564 active

Interventions: intervention 1: Placebo intervention 2: PG-760564 intervention 3: PG-760564 intervention 4: PG-760564 intervention 5: PG-760564
Intervention descriptions: intervention 1: oral capsule, 2x/day for 14 days intervention 2: oral capsule, 50 mg, 2x/day for 14 days intervention 3: oral capsule, 100mg, 2x/day for 14 days intervention 4: oral capsule, 200 mg, 2x/day for 14 days intervention 5: oral capsule, 400 mg, 2x/day for 14 days

Protocol document: