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

This study is not yet open for participant recruitment.
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
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 April 20, 2014