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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1029-006 | Other Identifier | Merck Protocol Number |
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This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose treatment with MK-1029 in adults with mild to moderate persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1029 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1029 | Drug | Five (5) X 100 mg capsules, orally, once daily for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 42 days after initial dose of study treatment |
| Number of Participants Who Discontinued Study Treatment Due to An Adverse Event | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Up to 28 days after initial dose of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026. | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose |
| Maximum Plasma Concentration (Cmax) of MK-1029 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call for Information | Costa Mesa | California | 92626 | United States | ||
| Call for Information |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-1029 | Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days. |
| FG001 | Placebo | Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo for MK-1029 |
| Drug |
Five (5) X 100 mg capsules, orally, once daily for 28 days |
|
Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026. |
| Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026. | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose |
| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Merck Sharp & Dohme | North Ryde | Australia |
| Merck Sharp & Dohme (New Zealand) Ltd., | Wellington | New Zealand |
| MSD (Pty) LTD South Africa | Midrand | South Africa |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-1029 | Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days. |
| BG001 | Placebo | Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | All participants who received at least one dose of study drug | Posted | Count of Participants | Participants | Up to 42 days after initial dose of study treatment |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026. | All participants who received study drug and had evaluable concentration values for AUC0-6 hours on Day 1 and Day 28 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose |
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| Secondary | Maximum Plasma Concentration (Cmax) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026. | All participants who received study drug and had evaluable concentration values for Cmax on Day 1 and Day 28 | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of MK-1029 | Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026. | All participants who received study drug and had evaluable concentration values for Tmax on Day 1 and Day 28 | Posted | Median | Full Range | Hours | Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose |
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| Primary | Number of Participants Who Discontinued Study Treatment Due to An Adverse Event | An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | All participants who received at least one dose of study drug | Posted | Count of Participants | Participants | Up to 28 days after initial dose of study treatment |
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Up to 42 days after initial dose of study treatment
All participants who received at least one dose of study drug
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-1029 | Participants received five 100 mg MK-1029 capsules, taken orally, once daily for 28 days. | 0 | 18 | 0 | 18 | 9 | 18 |
| EG001 | Placebo | Participants received five 100 mg placebo-matching MK-1029 capsules, taken orally, once daily for 28 days. | 0 | 9 | 0 | 9 | 3 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Otitis media viral | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Joint injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Male |
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