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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01370317




Registration number
NCT01370317
Ethics application status
Date submitted
8/06/2011
Date registered
9/06/2011
Date last updated
25/01/2019

Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
Scientific title
Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma
Secondary ID [1] 0 0
MK-1029-006
Secondary ID [2] 0 0
1029-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MK-1029
Treatment: Drugs - Placebo for MK-1029

Experimental: MK-1029 -

Placebo Comparator: Placebo -


Treatment: Drugs: MK-1029
Five (5) X 100 mg capsules, orally, once daily for 28 days

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 42 days after initial dose of study treatment
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Up to 28 days after initial dose of study treatment
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Merck Sharp & Dohme - North Ryde
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington
Country [3] 0 0
South Africa
State/province [3] 0 0
Midrand

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01370317
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme Corp.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications