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

Asthma Clinical Trial

Official title:

Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01370317
• Other study ID #: 1029-006
• Secondary ID: MK-1029-006
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2011
• Est. completion date: December 27, 2011

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 27, 2011
• Est. primary completion date: December 27, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MK-1029
Five (5) X 100 mg capsules, orally, once daily for 28 days
• Placebo for MK-1029
Five (5) X 100 mg capsules, orally, once daily for 28 days

Locations

Country	Name	City	State
Australia	Merck Sharp & Dohme	North Ryde
New Zealand	Merck Sharp & Dohme (New Zealand) Ltd.,	Wellington
South Africa	MSD (Pty) LTD South Africa	Midrand
United States	Call for Information	Costa Mesa	California
United States	Call for Information	Rolling Hills Estates	California

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029	Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.	Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Secondary	Maximum Plasma Concentration (Cmax) of MK-1029	Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.	Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Secondary	Time to Maximum Plasma Concentration (Tmax) of MK-1029	Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026.	Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose