Conditions: Healthy
Keywords: N91115 GSNORi SNO Cavosonstat
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 49
Healthy volunteers: yes

Brief summary:
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.

Detailed description:
This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.

Arms:
arm 1: single oral daily dose of 10 mg N91115 for 14 days arm 2: single oral daily dose of placebo for 14 days arm 3: single oral daily dose of 50 mg N91115 for 14 days arm 4: single oral dose of 50 mg N91115 arm 5: single oral daily dose of 250 mg N91115 for 14 days (fasted) arm 6: single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) arm 7: single oral daily dose of 500 mg N91115 for 14 days arm 8: Single oral dose of placebo (Day 1 only)

Interventions: intervention 1: N91115 intervention 2: Placebo intervention 3: N91115 intervention 4: Placebo-Day 1 only
Intervention descriptions: intervention 1: Given PO daily for 14 days intervention 2: Given PO daily for 14 days intervention 3: Given PO only on Day 1 intervention 4: Given PO- only on Day 1 (single dosed to match single dose treatments)

Protocol document: