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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0822-066 | Other Identifier | Protocol Number |
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This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of single doses of odanacatib in mature adolescents and young adults who are currently receiving glucocorticoid therapy. The primary hypotheses for the study are that a single dose of odanacatib is well tolerated in mature adolescents and following single dose administration of odanacatib 50 mg, there is no clinically important difference in AUC0-inf between mature adolescents and young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adolescents Odanacatib 10 mg | Experimental | Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents. |
|
| Adolescents Odanacatib 50 mg | Experimental | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents. |
|
| Adolescents Placebo | Placebo Comparator | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. |
|
| Young Adults Odanacatib 50 mg | Experimental | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults. |
|
| Young Adults Placebo | Placebo Comparator | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Odanacatib | Drug | single oral dose, tablets, 10 or 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Report an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to Day 14 |
| Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The Method of Dispersion is more accurately described as "Percent Geometric Coefficient of Variation". Pharmacokinetic (PK) analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The Method of Dispersion is more accurately described as "Percent Geometric Coefficient of Variation". PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose |
| Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Cmax is a measure of the maximum amount of drug in the plasma after the drug dose is given. The Method of Dispersion is more accurately described as "Percent Geometric Coefficient of Variation". PK analysis was not performed on participants receiving placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) at 168 Hours Postdose | Urinary aminoterminal crosslinked telopeptide of Type I collagen (uNTx/Cr) is a biochemical marker of bone resorption. Odanacatib selectively and potently inhibits cathepsin K (CatK), the primary catalyst of bone resorption. Since CatK is the enzyme responsible for bone matrix degradation it is possible to use bone resorption biomarkers to quantify pharmacodynamic effects in short term clinical studies. CatK cleaves the N-telopeptide of collagen type I to form NTx and also cleaves the serum C-terminal telopeptide of collagen type I (1-CTP - itself generated by the action of matrix metalloproteases) to generate CTx. Urine NTx measurements (in bone collagen equivalents [BCE]) have been normalized to creatinine clearance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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The Young Adults Odanacatib 10 mg arm represents historical data from a separate study (MK-0822-007). As such, these participants were not enrolled in any part of the current MK-0822-066 study.
Recruitment continued until the Odanacatib Development Program was discontinued on 02-Sep-2016. No participants were actively receiving treatment at the time of study discontinuation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adolescents Odanacatib 10 mg | Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents. |
| FG001 | Adolescents Odanacatib 50 mg | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents. |
| FG002 | Adolescents Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. |
| FG003 | Young Adults Odanacatib 10 mg | Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007). |
| FG004 | Young Adults Odanacatib 50 mg | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults. |
| FG005 | Young Adults Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of participants for analysis of baseline characteristics are the participants used for the pharmacokinetic and statistical analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adolescents Odanacatib 10 mg | Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents. |
| BG001 | Adolescents Odanacatib 50 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Report an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | The population analyzed consisted of all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to Day 14 |
|
Up to Day 14 (MK-0822-066) & Up to 408 hours post-dose (historical study MK-0822-007)
The population analyzed consisted of all randomized participants who received at least 1 dose of study drug. The Young Adults Odanacatib 10 mg arm represent historical data from a separate study (MK-0822-007). As such, these participants were not enrolled in any part of the current MK-0822-066 study.
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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 | Adolescents Odanacatib 10 mg | Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood potassium increased | Investigations | MedDRA 19.1 & 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & 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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|
| Placebo | Drug | single oral dose, tablets |
|
| Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Tmax is the time required to reach Cmax. PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Area Under the Plasma Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The AUC0-inf data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-inf data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| AUC0-168 for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Area Under the Plasma Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The AUC0-168 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-168 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose |
| Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. The Cmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Cmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Tmax is the time required to reach Cmax. The Tmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Tmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| Apparent Terminal t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Apparent terminal t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. The apparent terminal t1/2 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg apparent terminal t1/2 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
| Baseline (predose Day 1) and 168 hours postdose |
| Withdrawal by Subject |
|
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
| BG002 | Adolescents Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. |
| BG003 | Young Adults Odanacatib 10 mg | Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007). |
| BG004 | Young Adults Odanacatib 50 mg | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults. |
| BG005 | Young Adults Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults. |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents. |
| OG002 | Adolescents Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. |
| OG003 | Young Adults Odanacatib 50 mg | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults. |
| OG004 | Young Adults Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults. |
|
|
| Primary | Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The Method of Dispersion is more accurately described as "Percent Geometric Coefficient of Variation". Pharmacokinetic (PK) analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available AUC0-inf data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM·hr | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
| Primary | Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The Method of Dispersion is more accurately described as "Percent Geometric Coefficient of Variation". PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available AUC0-168 data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures. | Posted | Geometric Mean | Geometric Coefficient of Variation | μM·hr | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Cmax is a measure of the maximum amount of drug in the plasma after the drug dose is given. The Method of Dispersion is more accurately described as "Percent Geometric Coefficient of Variation". PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available Cmax data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures. | Posted | Geometric Mean | Geometric Coefficient of Variation | nM | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
| Primary | Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | Tmax is the time required to reach Cmax. PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available Tmax data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures. | Posted | Median | Full Range | Hours | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
| Primary | Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg | T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available t1/2 data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) at 168 Hours Postdose | Urinary aminoterminal crosslinked telopeptide of Type I collagen (uNTx/Cr) is a biochemical marker of bone resorption. Odanacatib selectively and potently inhibits cathepsin K (CatK), the primary catalyst of bone resorption. Since CatK is the enzyme responsible for bone matrix degradation it is possible to use bone resorption biomarkers to quantify pharmacodynamic effects in short term clinical studies. CatK cleaves the N-telopeptide of collagen type I to form NTx and also cleaves the serum C-terminal telopeptide of collagen type I (1-CTP - itself generated by the action of matrix metalloproteases) to generate CTx. Urine NTx measurements (in bone collagen equivalents [BCE]) have been normalized to creatinine clearance. | The population analyzed included all randomized, treated participants who had available uNTx/Cr data for Baseline and 168 hours. | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol[BCE]/mmol[creatinine]) | Baseline (predose Day 1) and 168 hours postdose |
|
|
|
| Primary | AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Area Under the Plasma Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The AUC0-inf data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-inf data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available AUC0-inf data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures. | Posted | Geometric Mean | 95% Confidence Interval | μM·hr | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
|
| Primary | AUC0-168 for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Area Under the Plasma Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The AUC0-168 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-168 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available AUC0-168 data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures. | Posted | Geometric Mean | 95% Confidence Interval | μM·hr | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose |
|
|
|
|
| Primary | Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. The Cmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Cmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available Cmax data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures. | Posted | Geometric Mean | 95% Confidence Interval | nM | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
|
| Primary | Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Tmax is the time required to reach Cmax. The Tmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Tmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available Tmax data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures. | Posted | Median | Full Range | Hours | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
| Primary | Apparent Terminal t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg | Apparent terminal t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. The apparent terminal t1/2 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg apparent terminal t1/2 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo. | The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available t1/2 data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose |
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Adolescents Odanacatib 50 mg | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents. | 0 | 3 | 0 | 3 |
| EG002 | Adolescents Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. | 0 | 3 | 0 | 3 |
| EG003 | Young Adults Odanacatib 50 mg | Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults. | 0 | 6 | 1 | 6 |
| EG004 | Young Adults Placebo | Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults. | 0 | 2 | 0 | 2 |
| EG005 | Young Adults Odanacatib 10 mg | Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults (historical study MK-0822-007). | 0 | 12 | 2 | 12 |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 19.1 & 13.0 | Systematic Assessment |
|
| Systemic lupus erythematosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 & 13.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 19.1 & 13.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 19.1 & 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 & 13.0 | Systematic Assessment |
|
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.
| D009750 |
| Nutritional and Metabolic Diseases |