A Single-Dose Study of MK-8351 in a Lung Allergen Challenge (MK-8351-003)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01926002
First received: August 16, 2013
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Low-Dose MK-8351
Drug: High-Dose MK-8351
Drug: Placebo to MK-8351
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • AUC0-3hr of FEV1 Percent Change From Baseline [ Time Frame: 3 Hours ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to 14 Days ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Treatment Due to AEs [ Time Frame: Up to 72 Hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AUC0-24h of MK-8351 [ Time Frame: Up to 24 Hours Post-Dose ] [ Designated as safety issue: No ]
  • AUC0-last of MK-8351 [ Time Frame: Up to 72 Hours Post-Dose ] [ Designated as safety issue: No ]
  • AUC0-∞ of MK-8351 [ Time Frame: Up to 72 Hours Post-Dose ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of MK-8351 [ Time Frame: Up to 72 Hours Post-Dose ] [ Designated as safety issue: No ]
  • Time to Maximum Plasma Concentration (Tmax) of MK-8351 [ Time Frame: Up to 72 Hours Post-Dose ] [ Designated as safety issue: No ]
  • Apparent Half-Life (t1/2) of MK-8351 [ Time Frame: Up to 72 Hours Post-Dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: September 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-Dose MK-8351
Low-dose MK-8351 administered as single inhaled dose.
Drug: Low-Dose MK-8351
Single administration of low-dose MK-8351.
Experimental: High-Dose MK-8351
High-dose MK-8351 administered as a single inhaled dose.
Drug: High-Dose MK-8351
High-Dose MK-8351 administered as a single inhaled dose.
Placebo Comparator: Placebo to MK-8351
Matching placebo to low-dose or high-dose MK-8351 administered as a single inhaled dose.
Drug: Placebo to MK-8351
Single-Dose Matching placebo to high-dose or low-dose MK-8351.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
  • 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.

Exclusion Criteria:

  • 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;
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926002

Contacts
Contact: Toll-Free Number 1-888-577-8839

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01926002     History of Changes
Other Study ID Numbers: 8351-003, MK-8351-003
Study First Received: August 16, 2013
Last Updated: January 30, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014