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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01370317
Ethics application status
Date submitted
8/06/2011
Date registered
9/06/2011

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
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
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
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
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
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
Sex
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
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/12/2011
Sample size
Target
Accrual to date
Final
27
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 LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01370317