AsthmaPhase 1NCT01370317
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma
A Phase 1 study testing MK-1029 in people with Asthma, run by Merck Sharp & Dohme LLC at 5 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- MK-1029
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 1 Jun 2011to 27 Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
Call for Information
Costa Mesa, California, 92626
Call for Information
Rolling Hills Estates, California, 90274
About this study
Official title: Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma
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.
- Conditions
- Asthma
- Being tested
- MK-1029, Placebo for MK-1029
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1029Drug
Five (5) X 100 mg capsules, orally, once daily for 28 days
Placebo for MK-1029Drug
Five (5) X 100 mg capsules, orally, once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| MK-1029 | Experimental | Not described Receives: Drug: MK-1029 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo for MK-1029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 42 days after initial dose of study treatment
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.
Measured: Up to 28 days after initial dose of study treatment
Secondary outcomes (3)
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.
Measured: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
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.
Measured: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
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.
Measured: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study start1 Jun 2011
- Primary completion27 Dec 2011
- Study completion27 Dec 2011
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370317
- Sponsor's protocol ID
- 1029-006
- Other IDs
- MK-1029-006
- Status last verified
- Aug 2018
- First submitted
- 8 Jun 2011
- Last updated
- 25 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-1029 or Placebo in Patients With Mild to Moderate Asthma
- ClinicalTrials.gov ID
- NCT01370317
- Acronym / sponsor ID
- 1029-006
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 27 Dec 2011 (actual)
- Study completion
- 27 Dec 2011 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 25 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-1029 | Experimental | Drug: MK-1029 |
| Placebo | Placebo comparator | Drug: Placebo for MK-1029 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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-1029Five (5) X 100 mg capsules, orally, once daily for 28 days | Drug | MK-1029 |
| Placebo for MK-1029Five (5) X 100 mg capsules, orally, once daily for 28 days | Drug | Placebo |
Primary outcome
Number of Participants Who Experienced One or More Adverse Events
Time frame: Up to 42 days after initial dose of study treatment
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.
Number of Participants Who Discontinued Study Treatment Due to An Adverse Event
Time frame: Up to 28 days after initial dose of study treatment
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.
3 secondary outcomes
Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029
Time frame: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Maximum Plasma Concentration (Cmax) of MK-1029
Time frame: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Time to Maximum Plasma Concentration (Tmax) of MK-1029
Time frame: Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 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
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MK-1029 in people with Asthma, run by Merck Sharp & Dohme LLC at 5 sites in 4 countries.
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 6 inclusion and 11 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, New Zealand, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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 25 Jan 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?
Number of Participants Who Experienced One or More Adverse Events (time frame: Up to 42 days after initial dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2019.