Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

Brief summary:
This was a 2-part study in participants with allergen-induced asthma. It included a procedural pilot component (Part 1). Part 1 tested the key procedures and timing of Part 2; no study drug was administered during Part 1. Part 2 included a pre-randomization placebo run-in (Period 1) and 3 treatment periods (Periods 2, 3, and 4) during which participants were randomized to receive double-blind placebo, MK-1029 60 mg or MK-1029 500 mg in a crossover design. The treatment periods were followed by a minimum 21-day washout. Part 2 assessed allergen-induced sputum eosinophils and allergen-induced late asthmatic response (LAR) compared to placebo.

Detailed description:

Arms:
arm 1: Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design arm 2: Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design arm 3: Part II - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design

Interventions: intervention 1: MK-1029 10 mg intervention 2: MK-1029 100 mg intervention 3: Placebo for MK-1029 10 mg intervention 4: Placebo for MK-1029 100 mg
Intervention descriptions: intervention 1: Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design intervention 2: Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design intervention 3: Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design." intervention 4: Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design

Protocol document: