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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01926002
• Other study ID #: 8351-003
• Secondary ID: MK-8351-003
• Status: Withdrawn
• Phase: Phase 1
• First received: August 16, 2013
• Last updated: July 15, 2015
• Start date: September 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Low-Dose MK-8351
Single administration of low-dose MK-8351.
• High-Dose MK-8351
High-Dose MK-8351 administered as a single inhaled dose.
• Placebo to MK-8351
Single-Dose Matching placebo to high-dose or low-dose MK-8351.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-3hr of FEV1 Percent Change From Baseline		3 Hours	No
Primary	Number of Participants Experiencing Adverse Events (AEs)		Up to 14 Days	Yes
Primary	Number of Participants Discontinuing Study Treatment Due to AEs		Up to 72 Hours	Yes
Secondary	AUC0-24h of MK-8351		Up to 24 Hours Post-Dose	No
Secondary	AUC0-last of MK-8351		Up to 72 Hours Post-Dose	No
Secondary	AUC0-8 of MK-8351		Up to 72 Hours Post-Dose	No
Secondary	Maximum Plasma Concentration (Cmax) of MK-8351		Up to 72 Hours Post-Dose	No
Secondary	Time to Maximum Plasma Concentration (Tmax) of MK-8351		Up to 72 Hours Post-Dose	No
Secondary	Apparent Half-Life (t1/2) of MK-8351		Up to 72 Hours Post-Dose	No