AsthmaPhase 1NCT01343407

A Two-part Study of the Effects of MK-1029 in Allergen-Challenged Asthmatics (MK-1029-003)

A Phase 1 study testing MK-1029 10 mg and MK-1029 100 mg in people with Asthma, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma
What is being tested?: MK-1029 10 mg and MK-1029 100 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: No sites listed yet
Study dates: 19 Apr 2011to 9 Jan 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Parts 1 and 2
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

Show all 12Show fewer

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 2 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

Who cannot join

Parts 1 and 2
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 β2-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

Show all 15Show fewer

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 2 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

About this study

Official 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

This was a 2-part study in participants with allergen-induced asthma. It included a procedural pilot component (Part 1). Part 1 tested the key procedures and timing of Part 2; no study drug was administered during Part 1. Part 2 included a pre-randomization placebo run-in (Period 1) and 3 treatment periods (Periods 2, 3, and 4) during which participants were randomized to receive double-blind placebo, MK-1029 60 mg or MK-1029 500 mg in a crossover design. The treatment periods were followed by a minimum 21-day washout. Part 2 assessed allergen-induced sputum eosinophils and allergen-induced late asthmatic response (LAR) compared to placebo.

Conditions: Asthma
Being tested: MK-1029 10 mg, MK-1029 100 mg, Placebo for MK-1029 10 mg, Placebo for MK-1029 100 mg
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-1029 10 mgDrug
Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
MK-1029 100 mgDrug
Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
Placebo for MK-1029 10 mgDrug
Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."
Placebo for MK-1029 100 mgDrug
Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design

Study groups in NCT01343407
Study group	Role	What they receive
MK-1029 60 mg	Experimental	Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design Receives: Drug: MK-1029 10 mg; Drug: Placebo for MK-1029 10 mg
MK-1029 500 mg	Experimental	Part 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design Receives: Drug: MK-1029 100 mg; Drug: Placebo for MK-1029 100 mg
Placebo	Placebo comparator	Part II - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design Receives: Drug: Placebo for MK-1029 10 mg; Drug: Placebo for MK-1029 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen
The effect of MK-1029 on the reduction of percent (%) sputum eosinophils following allergen challenge with standardized cat pelt or hair (CPH) allergen extract was assessed. Baseline % eosinophils were measured before treatment (and pre-allergen challenge) on Day -1. The change from baseline in allergen-induced % sputum eosinophils at 8 hr post allergen challenge testing on Day 5 was analyzed using a repeated measures linear mixed effects model with treatment, period, time, time-by-treatment interaction as fixed factors, and participant as a random factor. Outcome Measure 6 shows % eosinophil values at baseline.
Measured: Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)
Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)
The effect of MK-1029 on the FEV1 AUC(3-8hr) during LAR was assessed. The unit of measure for an FEV1 AUC value is L*hr. The effect of treatment on LAR was assessed as the percent-fall in FEV1 AUC(3-8hr), evaluated by spirometry following allergen challenge on Day 5. The FEV1 AUC(3-8hr) during LAR was analyzed using a linear mixed effects model with treatment and period as fixed factors and participant as a random factor.
Measured: From 3 to 8 hours after allergen challenge on Day 5 of each treatment period
Number of Participants With an Adverse Event (AE)
The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
Measured: Up to 26 days in each treatment period
Number of Participants Discontinuing Treatment Due to an AE
The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
Measured: Up to 5 days in each treatment period

Secondary outcomes (1)

Percent Inhibition of the Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils
The concentration of CD11b in whole blood samples was assessed. The percent-inhibition of CD11b (a cell-surface biomarker on activated eosinophils) was assessed following inhaled allergen challenge on Day 5. Inhibition of CD11b expression was assessed by analyzing the % inhibition of CD11b expression from baseline (Day -1) using a linear mixed-effects model with period, treatment, time, and treatment by time as fixed terms and subject as a random term. Outcome Measure 7 shows CD11b expression values at baseline.
Measured: Baseline (Day -1, predose), 24 hours after allergen challenge on Day 5 in each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20119 Jan 2012

First posted28 Apr 2011 (estimated)
Study start19 Apr 2011
Primary completion9 Jan 2012
Study completion9 Jan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01343407
Sponsor's protocol ID: 1029-003
Other IDs: 2010-022391-31, MK-1029-003
Status last verified: Feb 2019
First submitted: 26 Apr 2011
Last updated: 1 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT01343407
Acronym / sponsor ID: 1029-003
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 19 Apr 2011 (actual)
Primary completion: 9 Jan 2012 (actual)
Study completion: 9 Jan 2012 (actual)
First posted: 28 Apr 2011 (estimated)
Results: Posted 8 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
MK-1029 60 mg	Experimental	Drug: MK-1029 10 mg, Drug: Placebo for MK-1029 10 mgPart 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design
MK-1029 500 mg	Experimental	Drug: MK-1029 100 mg, Drug: Placebo for MK-1029 100 mgPart 2 - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design
Placebo	Placebo comparator	Drug: Placebo for MK-1029 10 mg, Drug: Placebo for MK-1029 100 mgPart II - Participants will receive 5 days of double-blind, once-daily MK-1029 60 mg followed by a 21-day washout in Period 2, 3, or 4 in a crossover design

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Parts 1 and 2
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

Key exclusion criteria (15 listed)

Parts 1 and 2
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MK-1029 10 mgSix capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design	Drug	MK-1029 60 mg
MK-1029 100 mgFive capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design	Drug	MK-1029 500 mg
Placebo for MK-1029 10 mgSix capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."	Drug	MK-1029 60 mg, Placebo
Placebo for MK-1029 100 mgFive capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design	Drug	MK-1029 500 mg, Placebo

Primary outcome

Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen
Time frame: Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)
The effect of MK-1029 on the reduction of percent (%) sputum eosinophils following allergen challenge with standardized cat pelt or hair (CPH) allergen extract was assessed. Baseline % eosinophils were measured before treatment (and pre-allergen challenge) on Day -1. The change from baseline in allergen-induced % sputum eosinophils at 8 hr post allergen challenge testing on Day 5 was analyzed using a repeated measures linear mixed effects model with treatment, period, time, time-by-treatment interaction as fixed factors, and participant as a random factor. Outcome Measure 6 shows % eosinophil values at baseline.
Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)
Time frame: From 3 to 8 hours after allergen challenge on Day 5 of each treatment period
The effect of MK-1029 on the FEV1 AUC(3-8hr) during LAR was assessed. The unit of measure for an FEV1 AUC value is L*hr. The effect of treatment on LAR was assessed as the percent-fall in FEV1 AUC(3-8hr), evaluated by spirometry following allergen challenge on Day 5. The FEV1 AUC(3-8hr) during LAR was analyzed using a linear mixed effects model with treatment and period as fixed factors and participant as a random factor.
Number of Participants With an Adverse Event (AE)
Time frame: Up to 26 days in each treatment period
The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.
Number of Participants Discontinuing Treatment Due to an AE
Time frame: Up to 5 days in each treatment period
The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.

1 secondary outcome

Percent Inhibition of the Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils
Time frame: Baseline (Day -1, predose), 24 hours after allergen challenge on Day 5 in each treatment period

Results and safety

Results posted to the registry on 8 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	2	2
Sequence 2	2	2
Sequence 3	3	3
Sequence 4	3	3
Sequence 5	3	3
Sequence 6	3	3

Primary outcome: Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen

Time frame: Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period). Least squares mean (95% Confidence Interval). Unit: Percent change

Measure	MK-1029 60 mg n = 11	MK-1029 500 mg n = 12	Placebo n = 9
Value	-10.6 (-22.5 to 1.3)	-7.3 (-18.3 to 3.6)	11.6 (-1.0 to 24.3)

MK-1029 60 mg vs Placebo: Difference in Least Squares Means (LSM): -22.2 (90% CI -35.7 to -8.7), p = 0.011, Linear mixed effects model
MK-1029 500 mg vs Placebo: Difference in LSM: -18.9 (90% CI -32.1 to -5.8), p = 0.023, Linear mixed effects model

Population analysed: Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.

Primary outcome: Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)

Time frame: From 3 to 8 hours after allergen challenge on Day 5 of each treatment period. Least squares mean (95% Confidence Interval). Unit: L*hr

Measure	MK-1029 60 mg n = 14	MK-1029 500 mg n = 16	Placebo n = 15
Value	41.24 (18.16 to 93.66)	49.76 (31.02 to 79.83)	86.37 (55.79 to 133.70)

MK-1029 60 mg vs Placebo: LS Mean Ratio (LSMR): 0.48 (90% CI 0.32 to 0.72), p = 0.006, Linear mixed effects model
MK-1029 500 mg vs Placebo: LS Mean Ratio (LSMR): 0.58 (90% CI 0.41 to 0.81), p = 0.012, Linear mixed effects model

Population analysed: Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.

Primary outcome: Number of Participants With an Adverse Event (AE)

Time frame: Up to 26 days in each treatment period. Count of participants. Unit: Participants

Measure	MK-1029 60 mg n = 14	MK-1029 500 mg n = 16	Placebo n = 16
Value	11	10	11

Population analysed: All randomized participants who received at least one dose of study treatment and had follow-up.

Primary outcome: Number of Participants Discontinuing Treatment Due to an AE

Time frame: Up to 5 days in each treatment period. Count of participants. Unit: Participants

Measure	MK-1029 60 mg n = 14	MK-1029 500 mg n = 16	Placebo n = 16
Value	0	0	1

Population analysed: All randomized participants who received at least one dose of study treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 26 days in each treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
60 mg MK-1029	0 of 14 (0%)	11 of 14 (78.6%)	0 of 14
500 mg MK-1029	0 of 16 (0%)	10 of 16 (62.5%)	0 of 16
Placebo	0 of 16 (0%)	11 of 16 (68.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MK-1029 10 mg and MK-1029 100 mg in people with Asthma, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen (time frame: Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01343407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019; AzTrials last refreshed its copy on 7 Nov 2026.