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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8351-003 | Other Identifier | Merck Study Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose MK-8351 | Experimental | Low-dose MK-8351 administered as single inhaled dose. |
|
| High-Dose MK-8351 | Experimental | High-dose MK-8351 administered as a single inhaled dose. |
|
| Placebo to MK-8351 | Placebo Comparator | Matching placebo to low-dose or high-dose MK-8351 administered as a single inhaled dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose MK-8351 | Drug | Single administration of low-dose MK-8351. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| High-Dose MK-8351 |
| Drug |
High-Dose MK-8351 administered as a single inhaled dose. |
|
| Placebo to MK-8351 | Drug | Single-Dose Matching placebo to high-dose or low-dose 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 |
| Apparent Half-Life (t1/2) of MK-8351 | Up to 72 Hours Post-Dose |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |