At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-Part, Multicenter, Randomized, Clinical Trial to Study the Effects of Multiple Doses of MK-1029 on the Late Asthmatic Response to Lung Allergen Challenge in Asthmatics
In Brief
A Phase 1 clinical trial evaluating MK-1029 10 mg, MK-1029 100 mg, and 2 other interventions for Asthma. Completed, enrolled 16 participants.
Detailed 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.
Study Details
Timeline
Interventions
Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."
Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design