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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_508 | Other Identifier | Merck | |
| MK-0822-059 |
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This study will test the weighted average inhibition of u-NTx/Cre (aminoterminal crosslinked telopeptide of Type 1 collagen) and AUC (0-168 hours) of Odanacatib
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A - Odanacatib | Experimental | Panel A - Healthy male subjects receiving Odanacatib |
|
| Panel A - Placebo | Placebo Comparator | Panel A - Healthy male subjects receiving placebo |
|
| Panel B - Odanacatib | Experimental | Panel B - Healthy female subjects receiving Odanacatib |
|
| Panel B - Placebo | Placebo Comparator | Panel B - Healthy female subjects receiving placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odanacatib | Drug | Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Average Inhibition (WAI) of Urine Aminoterminal Crosslinked Telopeptide of Type I Collagen (u-NTx/Cr) After Administration of Odanacatib 50 mg or Placebo Qw for 4 Weeks in Healthy Males and Postmenopausal Females | uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp [mean])*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model. | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state AUC0-168 hr of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Characterization of AUC0-168hr after administration of the final, Qw dose of Odanacatib 50 mg at steady state is reflective of the clinical dosing interval. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24276460 | Result | Anderson MS, Gendrano IN, Liu C, Jeffers S, Mahon C, Mehta A, Mostoller K, Zajic S, Morris D, Lee J, Stoch SA. Odanacatib, a selective cathepsin K inhibitor, demonstrates comparable pharmacodynamics and pharmacokinetics in older men and postmenopausal women. J Clin Endocrinol Metab. 2014 Feb;99(2):552-60. doi: 10.1210/jc.2013-1688. Epub 2013 Nov 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Males: Odanacatib (Panel A) | Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks |
| FG001 | Healthy Males: Placebo (Panel A) | Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks. |
| FG002 | Healthy Postmenopausal Females: Odanacatib (Panel B) | Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks |
| FG003 | Healthy Postmenopausal Females: Placebo (Panel B) | Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Males: Odanacatib (Panel A) | Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks |
| BG001 | Healthy Males: Placebo (Panel A) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline age in each of the four study treatment groups and the total study population |
| 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 | Weighted Average Inhibition (WAI) of Urine Aminoterminal Crosslinked Telopeptide of Type I Collagen (u-NTx/Cr) After Administration of Odanacatib 50 mg or Placebo Qw for 4 Weeks in Healthy Males and Postmenopausal Females | uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp [mean])*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model. | The population of male and postmenopausal female participants on Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. The population of male participants on placebo are also included. Postmenopausal females on placebo were not analyzed for WAI due to there being too few participants in this group (N=2). | Posted | Least Squares Mean | 90% Confidence Interval | Percent inhibition | Baseline to Week 4 |
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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 | Healthy Males: Odanacatib 50 mg (Panel A) | Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle branch block right | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp and Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C527128 | odanacatib |
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| Comparator: Placebo | Drug | Oral Placebo tablet administered once weekly for 4 consecutive weeks |
|
| Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
| Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Cmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. | Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
| Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained at 168 hours postdose on Day 22 (Week 4) to determine the similarity of steady-state C168hr (trough concentrations) of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. | Week 4 (168 hours postdose) |
| Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Tmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. | Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
| Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of the apparent t1/2 of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Harmonic mean, jack-knife standard deviation reported for apparent terminal t1/2. | Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
| Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of AEs experienced by participants receiving Odanacatib 50 mg Qw for 4 consecutive weeks was sufficiently low to permit continued clinical investigation. In addition to AEs during the treatment period and post-treatment follow-up period, AEs may have occurred prior to treatment in screened participants as a result of urine and blood sampling at Baseline. | Up to Day 58 |
| Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of participants who discontinued treatment with Odanacatib 50 mg Qw for 4 consecutive weeks due to AEs was sufficiently low to permit continued clinical investigation. | Up to Week 4 |
| Protocol Violation |
|
| Withdrawal by Subject |
|
Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
| BG002 | Healthy Postmenopausal Females: Odanacatib (Panel B) | Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks |
| BG003 | Healthy Postmenopausal Females: Placebo (Panel B) | Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Odanacatib (MK-0822) in Males (Panel A) | Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks |
| OG001 | Placebo in Males (Panel A) | Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks |
| OG002 | Odnacatib (MK-0822) in Postmenopausal Females (Panel B) | Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks |
| OG003 | Placebo in Postmenopausal Females (Panel B) | Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks |
|
|
|
| Secondary | Area Under the Curve of Plasma Concentration-time From 0 to 168 Hours (AUC0-168hr) of Odanacatib at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state AUC0-168 hr of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Characterization of AUC0-168hr after administration of the final, Qw dose of Odanacatib 50 mg at steady state is reflective of the clinical dosing interval. | The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. | Posted | Geometric Mean | 95% Confidence Interval | µM·hr | Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
|
|
|
|
| Secondary | Overall Maximum Concentration (Cmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Cmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. | The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. | Posted | Geometric Mean | 95% Confidence Interval | nM | Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
|
|
|
|
| Secondary | Concentration of Odanacatib at 168 Hours (C168hr) in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained at 168 hours postdose on Day 22 (Week 4) to determine the similarity of steady-state C168hr (trough concentrations) of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. | The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. | Posted | Geometric Mean | 95% Confidence Interval | nM | Week 4 (168 hours postdose) |
|
|
|
|
| Secondary | Overall Time to Maximum Concentration (Tmax) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of steady-state Tmax of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. | The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. | Posted | Median | Full Range | hr | Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
|
|
|
| Secondary | Apparent Terminal Half-Life (t1/2) of Odanacatib in Healthy Male and Postmenopausal Female Participants at Week 4 | Blood samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4) to determine the similarity of the apparent t1/2 of odanacatib 50 mg administered Qw for 4 weeks in healthy males and postmenopausal females. Harmonic mean, jack-knife standard deviation reported for apparent terminal t1/2. | The population of male and postmenopausal female participants who received Qw treatment with Odanacatib 50 mg for 4 weeks and were compliant with the protocol. | Posted | Mean | Standard Deviation | hr | Baseline, Week 4 (1, 2, 6, 12, 24, 48, 72, 96, 120, 144, 168, 240, and 336 hours post-dose) |
|
|
|
| Secondary | Number of Participants With At Least One Adverse Event (AE) in the Baseline, Treatment, or Post-Treatment Periods | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of AEs experienced by participants receiving Odanacatib 50 mg Qw for 4 consecutive weeks was sufficiently low to permit continued clinical investigation. In addition to AEs during the treatment period and post-treatment follow-up period, AEs may have occurred prior to treatment in screened participants as a result of urine and blood sampling at Baseline. | All randomized participants who received ≥1 dose of study treatment | Posted | Number | Participants | Up to Day 58 |
|
|
|
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, is also an AE. The study determined if the number of participants who discontinued treatment with Odanacatib 50 mg Qw for 4 consecutive weeks due to AEs was sufficiently low to permit continued clinical investigation. | All randomized participants who received ≥1 dose of study treatment | Posted | Number | Participants | Up to Week 4 |
|
|
|
| 0 |
| 23 |
| 8 |
| 23 |
| EG001 | Healthy Males: Placebo (Panel A) | Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks | 0 | 9 | 5 | 9 |
| EG002 | Postmenopausal Females: Odanacatib 50 mg (Panel B) | Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks | 0 | 10 | 7 | 10 |
| EG003 | Postmenopausal Females: Placebo (Panel B) | Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks | 0 | 2 | 2 | 2 |
| Dry eye | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Mycotic allergy | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Splinter | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
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| Blood urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
The SPONSOR has 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. SPONSOR review can be expedited to meet publication guidelines.
| D009750 |
| Nutritional and Metabolic Diseases |