Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

NCT01370317 | Completed Phase 1 Results

• 2 other identifiers: 1029-006MK-1029-006
• Study Type: interventional
• Target: 27
• Locations: 4 countries
• Sites: 5

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose treatment with MK-1029 in adults with mild to moderate persistent asthma.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced One or More Adverse Events

  An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  Up to 42 days after initial dose of study treatment

• Number of Participants Who Discontinued Study Treatment Due to An Adverse Event

  An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  Up to 28 days after initial dose of study treatment

Secondary Outcomes (3)

• Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029

  Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

• Maximum Plasma Concentration (Cmax) of MK-1029

  Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

• Time to Maximum Plasma Concentration (Tmax) of MK-1029

  Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

Study Arms (2)

MK-1029

EXPERIMENTAL

Drug: MK-1029

Placebo

PLACEBO COMPARATOR

Drug: Placebo for MK-1029

Interventions

MK-1029 DRUG

Five (5) X 100 mg capsules, orally, once daily for 28 days

MK-1029

Placebo for MK-1029 DRUG

Five (5) X 100 mg capsules, orally, once daily for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• If female, must be of non-childbearing potential
• Have a history of mild to moderate asthma for at least 6 months
• Other than asthma, in general good health
• Able to perform reproducible pulmonary function testing
• Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months
• Have body mass index (BMI) ≥17 kg/m\^2, but ≤35 kg/m\^2

You may not qualify if:

• Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of \>20% from the Screening Visit to the Baseline Visit
• Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit on any 2 consecutive days prior to the Baseline Visit
• Require the use of \>8 inhalations per day of short-acting beta2-agonist metered dose inhaler (MDI) or \>2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit up to the Baseline Visit
• Experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists \[SABA\]) at any time from the Screening Visit up to the Baseline Visit
• Have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma
• Require the chronic use of high-dose inhaled corticosteroids
• Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease, other than asthma
• Have a history of any illness that might confound the results of the study or poses additional risk to the participant
• Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection
• Is nursing
• Have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (5)

Call for Information

Costa Mesa, California, 92626, United States

Location

Call for Information

Rolling Hills Estates, California, 90274, United States

Location

Merck Sharp & Dohme

North Ryde, Australia

Location

Merck Sharp & Dohme (New Zealand) Ltd.,

Wellington, New Zealand

Location

MSD (Pty) LTD South Africa

Midrand, South Africa

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 9, 2011
• Study Start: June 1, 2011
• Primary Completion: December 27, 2011
• Study Completion: December 27, 2011
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); US (2); ZA (1); NZ (1)