A Single-Dose Study of MK-8351 in a Lung Allergen Challenge (MK-8351-003)
This study has been withdrawn prior to enrollment.
Merck Sharp & Dohme Corp.
First Posted: August 20, 2013
Last Update Posted: July 16, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Asthma||Drug: Low-Dose MK-8351 Drug: High-Dose MK-8351 Drug: Placebo to MK-8351||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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|
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 ]
- 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 ]
Secondary Outcome Measures:
- 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 ]
|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)|
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.
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.
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