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

NCT01926002 | Withdrawn Phase 1

• 2 other identifiers: 8351-003MK-8351-003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (3)

• AUC0-3hr of FEV1 Percent Change From Baseline

  3 Hours

• Number of Participants Experiencing Adverse Events (AEs)

  Up to 14 Days

• Number of Participants Discontinuing Study Treatment Due to AEs

  Up to 72 Hours

Secondary Outcomes (6)

• AUC0-24h of MK-8351

  Up to 24 Hours Post-Dose

• AUC0-last of MK-8351

  Up to 72 Hours Post-Dose

• AUC0-∞ of MK-8351

  Up to 72 Hours Post-Dose

• Maximum Plasma Concentration (Cmax) of MK-8351

  Up to 72 Hours Post-Dose

• Time to Maximum Plasma Concentration (Tmax) of MK-8351

  Up to 72 Hours Post-Dose

Study Arms (3)

Low-Dose MK-8351

EXPERIMENTAL

Low-dose MK-8351 administered as single inhaled dose.

Drug: Low-Dose MK-8351

High-Dose MK-8351

EXPERIMENTAL

High-dose MK-8351 administered as a single inhaled dose.

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.

Drug: Placebo to MK-8351

Interventions

Low-Dose MK-8351 DRUG

Single administration of low-dose MK-8351.

Low-Dose MK-8351

High-Dose MK-8351 DRUG

High-Dose MK-8351 administered as a single inhaled dose.

High-Dose MK-8351

Placebo to MK-8351 DRUG

Single-Dose Matching placebo to high-dose or low-dose MK-8351.

Placebo to MK-8351

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2013
• First Posted: August 20, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 16, 2015

Record last verified: 2015-07