Trial Outcomes & Findings for A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066) (NCT NCT01630616)
NCT ID: NCT01630616
Last Updated: 2018-08-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Up to Day 14
Results posted on
2018-08-28
Participant Flow
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.
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.
Participant milestones
| Measure |
Adolescents Odanacatib 10 mg
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
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).
|
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.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
3
|
12
|
6
|
2
|
|
Overall Study
COMPLETED
|
5
|
3
|
3
|
9
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Adolescents Odanacatib 10 mg
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
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).
|
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.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)
Baseline characteristics by cohort
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
n=3 Participants
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 10 mg
n=9 Participants
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).
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
n=2 Participants
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.8 Years
FULL_RANGE 1.6 • n=99 Participants
|
15.7 Years
FULL_RANGE 0.6 • n=107 Participants
|
16.3 Years
FULL_RANGE 0.6 • n=206 Participants
|
26.6 Years
FULL_RANGE 1.6 • n=157 Participants
|
22.3 Years
FULL_RANGE 0.0 • n=390 Participants
|
20 Years
n=16 Participants
|
20.8 Years
FULL_RANGE 3.4 • n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
13 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
15 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: The population analyzed consisted of all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
n=3 Participants
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
n=2 Participants
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Report an Adverse Event (AE)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
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
|
—
|
21.6 μM·hr
Geometric Coefficient of Variation 30.7
|
—
|
27.2 μM·hr
Geometric Coefficient of Variation 40.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
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
|
—
|
18.7 μM·hr
Geometric Coefficient of Variation 24.0
|
—
|
21.5 μM·hr
Geometric Coefficient of Variation 39.8
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
|
—
|
256 nM
Geometric Coefficient of Variation 30.8
|
—
|
237 nM
Geometric Coefficient of Variation 51.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
Tmax is the time required to reach Cmax. PK analysis was not performed on participants receiving placebo.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
|
—
|
6.0 Hours
Interval 2.0 to 24.0
|
—
|
9.0 Hours
Interval 1.0 to 24.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
|
—
|
66.9 Hours
Geometric Coefficient of Variation 30.4
|
—
|
77.3 Hours
Geometric Coefficient of Variation 20.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=9 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
|
10 μM·hr
Interval 7.5 to 13.3
|
—
|
—
|
11.3 μM·hr
Interval 9.1 to 13.9
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=9 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
AUC0-168 for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
|
8.1 μM·hr
Interval 6.2 to 10.7
|
—
|
—
|
9.3 μM·hr
Interval 7.6 to 11.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=9 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
|
99.6 nM
Interval 75.0 to 132.4
|
—
|
—
|
122.3 nM
Interval 99.0 to 151.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=9 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
|
6.0 Hours
Interval 6.0 to 24.0
|
—
|
—
|
6.0 Hours
Interval 4.0 to 32.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dosePopulation: 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.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=9 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Apparent Terminal t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
|
80.5 Hours
Geometric Coefficient of Variation 17.9
|
—
|
—
|
73.0 Hours
Geometric Coefficient of Variation 23.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (predose Day 1) and 168 hours postdosePopulation: The population analyzed included all randomized, treated participants who had available uNTx/Cr data for Baseline and 168 hours.
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.
Outcome measures
| Measure |
Adolescents Odanacatib 10 mg
n=5 Participants
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
n=3 Participants
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 Participants
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
n=2 Participants
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) at 168 Hours Postdose
|
0.79 nmol[BCE]/mmol[creatinine])
Geometric Coefficient of Variation 50.68
|
0.40 nmol[BCE]/mmol[creatinine])
Geometric Coefficient of Variation 232.0
|
1.03 nmol[BCE]/mmol[creatinine])
Geometric Coefficient of Variation 3.39
|
0.36 nmol[BCE]/mmol[creatinine])
Geometric Coefficient of Variation 53.62
|
0.83 nmol[BCE]/mmol[creatinine])
Geometric Coefficient of Variation 13.53
|
—
|
Adverse Events
Adolescents Odanacatib 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adolescents Odanacatib 50 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adolescents Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Young Adults Odanacatib 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Young Adults Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Young Adults Odanacatib 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adolescents Odanacatib 10 mg
n=5 participants at risk
Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Odanacatib 50 mg
n=3 participants at risk
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
|
Adolescents Placebo
n=3 participants at risk
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
|
Young Adults Odanacatib 50 mg
n=6 participants at risk
Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
|
Young Adults Placebo
n=2 participants at risk
Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
|
Young Adults Odanacatib 10 mg
n=12 participants at risk
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).
|
|---|---|---|---|---|---|---|
|
Investigations
Blood potassium increased
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/2 • 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.
|
0.00%
0/12 • 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.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
20.0%
1/5 • Number of events 1 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/2 • 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.
|
0.00%
0/12 • 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.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosis
|
0.00%
0/5 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
0.00%
0/2 • 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.
|
0.00%
0/12 • 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.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/2 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/5 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/2 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/3 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/2 • 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.
|
8.3%
1/12 • Number of events 1 • 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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER