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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01343407




Registration number
NCT01343407
Ethics application status
Date submitted
26/04/2011
Date registered
26/04/2011
Date last updated
24/02/2016

Titles & IDs
Public title
A Two-part Study of the Effects of MK-1029 in Allergen-challenged Asthmatics (MK-1029-003 AM1)
Scientific title
A Two-Part, Multicenter, Randomized, Clinical Trial to Study the Effects of Multiple Doses of MK-1029 on the Late Asthmatic Response to Lung Allergen Challenge in Asthmatics
Secondary ID [1] 0 0
2010-022391-31
Secondary ID [2] 0 0
1029-003
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MK-1029 10 mg
Treatment: Drugs - MK-1029 100 mg
Treatment: Drugs - Placebo for MK-1029 10 mg
Treatment: Drugs - Placebo for MK-1029 100 mg

Experimental: 60 mg MK-1029 - Part II - Participants will receive 60 mg MK-1029 in one out of four study periods

Experimental: 500 mg MK-1029 - Part II - Participants will receive 500 mg MK-1029 in one out of four study periods

Placebo Comparator: Placebo - Part II - Participants will receive placebo to MK-1029 in two out of four study periods


Treatment: Drugs: MK-1029 10 mg
Six capsules once daily for 5 days

Treatment: Drugs: MK-1029 100 mg
Five capsules once daily for 5 days

Treatment: Drugs: Placebo for MK-1029 10 mg
Six capsules once daily for 5 days

Treatment: Drugs: Placebo for MK-1029 100 mg
Five capsules once daily for 5 days

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

Outcomes
Primary outcome [1] 0 0
Change from baseline in the percentage of eosinophils in induced sputum
Timepoint [1] 0 0
Baseline (Day -1) and 8 hours after allergen challenge (Day 5)
Primary outcome [2] 0 0
Forced expiratory volume at 1 second (FEV1) area under the curve from 3 to 8 hours (AUC[3-8hr])
Timepoint [2] 0 0
Hour 3 to Hour 8 after allergen challenge (Day 5)
Secondary outcome [1] 0 0
Percentage inhibition of eosinophil CD11b expression
Timepoint [1] 0 0
Baseline (Day 1 predose) and 24 hours after dosing on Day 5

Eligibility
Key inclusion criteria
Parts I and II

- 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 II 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parts I and II

- 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 ß2-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 II 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

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
Crossover
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
New Zealand
State/province [1] 0 0
Wellington
Country [2] 0 0
South Africa
State/province [2] 0 0
Midrand
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Hertfordshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Part I of the study will verify optimal execution of the procedures and acquisition of
satisfactory samples that will be utilized in the main study (Part II); no drug will be
administered. Part II will assess the effect of multiple doses of MK-1029 on the changes in
allergen-induced sputum eosinophils and changes in allergen-induced late asthmatic response
(LAR) when compared to placebo.
Trial website
https://clinicaltrials.gov/show/NCT01343407
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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