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

NCT ID: NCT01343407

Last Updated: 2019-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-19
• Study Completion Date: 2012-01-09

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-1029 60 mg

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

Group Type: EXPERIMENTAL

MK-1029 10 mg

Intervention Type: DRUG

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

Placebo for MK-1029 10 mg

Intervention Type: DRUG

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

MK-1029 500 mg

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

Group Type: EXPERIMENTAL

MK-1029 100 mg

Intervention Type: DRUG

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

Placebo for MK-1029 100 mg

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo for MK-1029 10 mg

Intervention Type: DRUG

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

Placebo for MK-1029 100 mg

Intervention Type: DRUG

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

Interventions

MK-1029 10 mg

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

Intervention Type: DRUG

MK-1029 100 mg

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

Intervention Type: 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."

Intervention Type: DRUG

Placebo for MK-1029 100 mg

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Parts 1 and 2

• Is male or a female of non-childbearing potential
• Has a history of allergen-induced asthma for at least 6 months
• Is judged to be in good health (other than asthma)
• Is able to perform reproducible pulmonary function testing
• Has a positive methacholine challenge test on Day -1
• Has an allergic response to house dust mite allergen as defined by positive skin prick test
• Is a nonsmoker and/ or has not used nicotine or nicotine-containing products for at least 12 months
• Has body mass index (BMI) ≥17 kg/m^2, but ≤33 kg/m^2

Part 2 only

• Must demonstrate a dual airway response to an allergen challenge in Period 1, decrease in FEV1 of at least 20% 0 to 2 hours after allergen challenge for early asthmatic response (EAR) and a positive late asthmatic response (LAR) to an inhaled allergen challenge as defined by a bronchoconstrictive response of at least 15% reduction in FEV1 3 to 8 hours after allergen challenge
• Can tolerate sputum induction and produce adequate sputum

Exclusion Criteria

Parts 1 and 2

• Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses additional risk to the participant
• Has recent (4 weeks) or ongoing upper or lower respiratory tract infection
• Is unable to refrain from or anticipates the use of any medication other than the ones permitted in this study
• Has taken oral, intramuscular, intra-articular, high-potency topical or orally inhaled corticosteroids within 8 weeks
• Has taken the following medications outside the washout margins: nasal corticosteroids and anti-leukotrienes within 3 weeks; inhaled long-acting β2-agonists, long-acting antihistamines (e.g., loratadine, sustained-release agents), intra-nasal anticholinergics over-the-counter decongestants within 1 week; short-acting oral decongestants, short-acting antihistamines (e.g., chlorpheniramine) within 48 hours
• Consumes excessive amounts of alcohol or caffeinated beverages
• Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 3 months
• Has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• Is a nursing mother
• Has a history of receiving anti-immunoglobulin E (IgE) or immunotherapy
• Has a history of serious allergies to drugs or a history of hypersensitivity to mometasone furoate or any of its inactive ingredients such as lactose, or inhaled salbutamol, antihistamines, or any

other potential asthma/anaphylaxis rescue medication

Part 2 only

• Has a decline in FEV1 of 70% or greater from the post allergen diluent baseline and/or FEV1 <1.0L or has symptomatic drop in FEV1 associated with shortness of breath unresolved with bronchodilators within a reasonable timeframe (60 minutes) after the allergen challenge study in Period 1

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2010-022391-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-1029-003

Identifier Type: OTHER

Identifier Source: secondary_id

1029-003

Identifier Type: -

Identifier Source: org_study_id