AsthmaPhase 1NCT01926002
A Single-Dose Study of MK-8351 in a Lung Allergen Challenge (MK-8351-003)
A Phase 1 study testing Low-Dose MK-8351 and High-Dose MK-8351 in people with Asthma, run by Merck Sharp & Dohme LLC.
Trial summary
The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of forced expiratory volume (FEV1) when compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- Low-Dose MK-8351 and High-Dose MK-8351
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Females of non-childbearing potential (at least 1 year post-menopausal, post-hysterectomy, post-oophorectomy, or with tubal ligation);
- Males with a female partner of childbearing potential must agree to use a medically acceptable method of contraception during and up to 120 days after the last dose of study medication;
- Body Mass Index (BMI) >=17 kg/m^2 and <=33 kg/m^2
- Non-smoker and non-user of nicotine or nicotine-containing products for at least 6 months prior to enrollment;
- History of allergen-induced asthma for at least 6 months prior to enrollment;
- Able to perform reproducible pulmonary function testing;
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- Positive methacholine challenge test prior to receiving study medication;
- Allergic response to house dust mite allergen or standardized cat pelt or hair allergen extract;
- Ability to tolerate sputum induction and to produce adequate sputum.
Who cannot join
- History of clinically significant disease or disorder;
- History of malignancy;
- History of significant multiple and/or severe allergies;
- History of milk or lactose allergies or intolerance;
- History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
- Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibodies;
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- History of major surgery within 3 months prior to enrollment;
- Participation in another investigational trial within 4 weeks of screening;
- Lactating females;
- Inability to refrain from, or anticipates the use of, any medication including herbal remedies during the trial period;
- History of receiving anti-immunoglobulin E (IgE) or immunotherapy;
- History of serious allergies to drug or a history of hypersensitivity to inhaled salbutamol, antihistamines, or any other potential asthma/anaphylaxis rescue medication;
- History of hospitalization for asthma-related illness within 3 months of screening;
- History of emergent care more than twice in the last 12 months for asthma-related illness;
- History of life-threatening asthma;
- Consumes >4 glasses of alcoholic beverage per day;
- Consumes >6 servings of coffee, tea, cola, energy drinks or other caffeinated beverages per day;
- History or or current use of illicit drugs within past 24 months.
About this study
Official title: A Multicenter Randomized Clinical Trial to Study the Effects of Single Doses of MK-8351 on the Early Asthmatic Response to a Lung Allergen Challenge
The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of forced expiratory volume (FEV1) when compared to placebo.
Read the detailed description
This is a randomized, placebo-controlled, 4-period study. Eligible patients will undergo a single-blind phase in Period 1, followed by 3 periods during which they will receive low-dose MK-8351, high-dose MK-8351, or matching placebo as a single dose in a random sequence crossover study design.
- Conditions
- Asthma
- Being tested
- Low-Dose MK-8351, High-Dose MK-8351, Placebo to MK-8351
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose MK-8351Drug
Single administration of low-dose MK-8351.
High-Dose MK-8351Drug
High-Dose MK-8351 administered as a single inhaled dose.
Placebo to MK-8351Drug
Single-Dose Matching placebo to high-dose or low-dose MK-8351.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose MK-8351 | Experimental | Low-dose MK-8351 administered as single inhaled dose. Receives: Drug: Low-Dose MK-8351 |
| High-Dose MK-8351 | Experimental | High-dose MK-8351 administered as a single inhaled dose. Receives: Drug: High-Dose MK-8351 |
| Placebo to MK-8351 | Placebo comparator | Matching placebo to low-dose or high-dose MK-8351 administered as a single inhaled dose. Receives: Drug: Placebo to MK-8351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-3hr of FEV1 Percent Change From Baseline
Measured: 3 Hours
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to 14 Days
Number of Participants Discontinuing Study Treatment Due to AEs
Measured: Up to 72 Hours
Secondary outcomes (6)
AUC0-24h of MK-8351
Measured: Up to 24 Hours Post-Dose
AUC0-last of MK-8351
Measured: Up to 72 Hours Post-Dose
AUC0-∞ of MK-8351
Measured: Up to 72 Hours Post-Dose
Maximum Plasma Concentration (Cmax) of MK-8351
Measured: Up to 72 Hours Post-Dose
Time to Maximum Plasma Concentration (Tmax) of MK-8351
Measured: Up to 72 Hours Post-Dose
Apparent Half-Life (t1/2) of MK-8351
Measured: Up to 72 Hours Post-Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926002
- Sponsor's protocol ID
- 8351-003
- Other IDs
- MK-8351-003
- Status last verified
- Jul 2015
- First submitted
- 16 Aug 2013
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Clinical Trial to Study the Effects of Single Doses of MK-8351 on the Early Asthmatic Response to a Lung Allergen Challenge
- ClinicalTrials.gov ID
- NCT01926002
- Acronym / sponsor ID
- 8351-003
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary hypothesis of the study is single doses of MK-8351 will reduce the baseline early asthmatic response (EAR) as assessed by area under the curve from 0-3 hours (AUC0-3hr) of forced expiratory volume (FEV1) when compared to placebo.
Detailed description
This is a randomized, placebo-controlled, 4-period study. Eligible patients will undergo a single-blind phase in Period 1, followed by 3 periods during which they will receive low-dose MK-8351, high-dose MK-8351, or matching placebo as a single dose in a random sequence crossover study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-Dose MK-8351 | Experimental | Drug: Low-Dose MK-8351Low-dose MK-8351 administered as single inhaled dose. |
| High-Dose MK-8351 | Experimental | Drug: High-Dose MK-8351High-dose MK-8351 administered as a single inhaled dose. |
| Placebo to MK-8351 | Placebo comparator | Drug: Placebo to MK-8351Matching placebo to low-dose or high-dose MK-8351 administered as a single inhaled dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Females of non-childbearing potential (at least 1 year post-menopausal, post-hysterectomy, post-oophorectomy, or with tubal ligation);
- Males with a female partner of childbearing potential must agree to use a medically acceptable method of contraception during and up to 120 days after the last dose of study medication;
- Body Mass Index (BMI) >=17 kg/m^2 and <=33 kg/m^2
- Non-smoker and non-user of nicotine or nicotine-containing products for at least 6 months prior to enrollment;
- History of allergen-induced asthma for at least 6 months prior to enrollment;
Key exclusion criteria (18 listed)
- History of clinically significant disease or disorder;
- History of malignancy;
- History of significant multiple and/or severe allergies;
- History of milk or lactose allergies or intolerance;
- History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food;
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 |
|---|---|---|
| Low-Dose MK-8351Single administration of low-dose MK-8351. | Drug | Low-Dose MK-8351 |
| High-Dose MK-8351High-Dose MK-8351 administered as a single inhaled dose. | Drug | High-Dose MK-8351 |
| Placebo to MK-8351Single-Dose Matching placebo to high-dose or low-dose MK-8351. | Drug | Placebo to MK-8351 |
Primary outcome
AUC0-3hr of FEV1 Percent Change From Baseline
Time frame: 3 Hours
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 14 Days
Number of Participants Discontinuing Study Treatment Due to AEs
Time frame: Up to 72 Hours
6 secondary outcomes
AUC0-24h of MK-8351
Time frame: Up to 24 Hours Post-Dose
AUC0-last of MK-8351
Time frame: Up to 72 Hours Post-Dose
AUC0-∞ of MK-8351
Time frame: Up to 72 Hours Post-Dose
Maximum Plasma Concentration (Cmax) of MK-8351
Time frame: Up to 72 Hours Post-Dose
Time to Maximum Plasma Concentration (Tmax) of MK-8351
Time frame: Up to 72 Hours Post-Dose
Apparent Half-Life (t1/2) of MK-8351
Time frame: Up to 72 Hours Post-Dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low-Dose MK-8351 and High-Dose MK-8351 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 9 inclusion and 18 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: withdrawn, as of the sponsor's last update on 16 Jul 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
AUC0-3hr of FEV1 Percent Change From Baseline (time frame: 3 Hours). The study lists 3 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 16 Jul 2015.