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A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003)

NCT01343407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-03-01

Study results available
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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.

Conditions

Interventions

DRUG

MK-1029 10 mg

Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design

DRUG

MK-1029 100 mg

Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design

DRUG

Placebo for MK-1029 10 mg

Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."

DRUG

Placebo for MK-1029 100 mg

Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-19
Primary Completion
2012-01-09
Completion
2012-01-09

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343407 on ClinicalTrials.gov