OsteoporosisPhase 1NCT01630616

A Study of Odanacatib When Administered to Adolescents and Young Adults Treated With Glucocorticoids (MK-0822-066)

A Phase 1 study testing Odanacatib in people with Osteoporosis, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 12 to 25 years
Conditions the study is for: Osteoporosis
What is being tested?: Odanacatib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 19 participants
Where: No sites listed yet
Study dates: 12 Mar 2013to 14 Jul 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Female participants of reproductive potential (or other female subjects at the discretion of the investigator) must have negative serum pregnancy test and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study
Receiving glucocorticoid therapy at a dose anticipated to be stable over the course of the study period
X-ray evidence of closed epiphyses (growth plate) at the hand
Nonsmoker

Who cannot join

Pregnant or unwilling to undergo pregnancy test
History of stroke, chronic seizures, or major neurological disorder
History of malignant neoplastic disease (cancer)
Breastfeeding
Primary growth disorder
Any disease affecting the stomach or proximal small intestine resulting in malabsorption

Show all 16Show fewer

Received treatment which might have influenced bone turnover, including anabolic steroids, testosterone, calcitonin, calcitriol, alfacalcidol, excess vitamin A or excess vitamin D, or cyclosporine or initiation of use of birth control pills (estrogen-progestin combinations or progestin only, or depo provera) or other estrogen containing medications, or thyroid hormone unless on a stable dose for at least 1 month and has a normally functioning thyroid gland
Previous treatment with any marketed or experimental bisphosphonate within 12 months
History of, or evidence for, any clinically relevant metabolic bone disease (other than glucocorticoid-induced bone loss) including but not limited to primary hyperparathyroidism, hypoparathyroidism, hyperthyroidism, osteomalacia, and osteogenesis imperfecta within previous 3 years
History of hypothyroidism
Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day
Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day
Has had major surgery, donated or lost 1 unit of blood (approximately 500 mL), or participated in another investigational study within 4 weeks
History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
Regular user (including "recreational use") of any illicit drugs, or has a history of drug or alcohol abuse
Unable to swallow tablets

About this study

Official title: A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated With Glucocorticoids

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.

Conditions: Osteoporosis
Being tested: Odanacatib, Placebo
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OdanacatibDrug
Also called MK-0822
single oral dose, tablets, 10 or 50 mg
PlaceboDrug
single oral dose, tablets

Study groups in NCT01630616
Study group	Role	What they receive
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. Receives: Drug: Odanacatib
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. Receives: Drug: Odanacatib
Adolescents Placebo	Placebo comparator	Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents. Receives: Drug: Placebo
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. Receives: Drug: Odanacatib
Young Adults Placebo	Placebo comparator	Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose

Secondary outcomes (1)

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.
Measured: Baseline (predose Day 1) and 168 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 201314 Jul 2016

First posted28 Jun 2012 (estimated)
Study start12 Mar 2013
Primary completion14 Jul 2016
Study completion14 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01630616
Sponsor's protocol ID: 0822-066
Other IDs: MK-0822-066
Status last verified: Jul 2018
First submitted: 26 Jun 2012
Last updated: 28 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
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Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated With Glucocorticoids
ClinicalTrials.gov ID: NCT01630616
Acronym / sponsor ID: 0822-066
Conditions: Osteoporosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 19 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 12 Mar 2013 (actual)
Primary completion: 14 Jul 2016 (actual)
Study completion: 14 Jul 2016 (actual)
First posted: 28 Jun 2012 (estimated)
Results: Posted 9 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Adolescents Odanacatib 10 mg	Experimental	Drug: OdanacatibStudy drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
Adolescents Odanacatib 50 mg	Experimental	Drug: OdanacatibStudy drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
Adolescents Placebo	Placebo comparator	Drug: PlaceboStudy drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
Young Adults Odanacatib 50 mg	Experimental	Drug: OdanacatibStudy 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	Drug: PlaceboStudy drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.

Who may qualify

Ages: 12 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Female participants of reproductive potential (or other female subjects at the discretion of the investigator) must have negative serum pregnancy test and agree to use (and/or have their partner use) two (2) acceptable methods of birth control beginning at the prestudy visit throughout the study and until 2 weeks after the dose of study
Receiving glucocorticoid therapy at a dose anticipated to be stable over the course of the study period
X-ray evidence of closed epiphyses (growth plate) at the hand
Nonsmoker

Key exclusion criteria (16 listed)

Pregnant or unwilling to undergo pregnancy test
History of stroke, chronic seizures, or major neurological disorder
History of malignant neoplastic disease (cancer)
Breastfeeding
Primary growth disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OdanacatibAlso: MK-0822single oral dose, tablets, 10 or 50 mg	Drug	Adolescents Odanacatib 10 mg, Adolescents Odanacatib 50 mg, Young Adults Odanacatib 50 mg
Placebosingle oral dose, tablets	Drug	Adolescents Placebo, Young Adults Placebo

Primary outcome

Number of Participants Who Report an Adverse Event (AE)
Time frame: Up to Day 14
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.
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
Time frame: 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 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.
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
Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose
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.
Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
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.
Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
Tmax is the time required to reach Cmax. PK analysis was not performed on participants receiving placebo.
Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg
Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
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.
AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
Time frame: 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 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.
AUC0-168 for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose
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.
Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
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.
Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose
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.
Apparent Terminal t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg
Time frame: 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 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.

1 secondary outcome

Change From Baseline in Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) at 168 Hours Postdose
Time frame: Baseline (predose Day 1) and 168 hours postdose

Results and safety

Results posted to the registry on 9 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adolescents Odanacatib 10 mg	5	5
Adolescents Odanacatib 50 mg	3	3
Adolescents Placebo	3	3
Young Adults Odanacatib 10 mg	12	9
Young Adults Odanacatib 50 mg	6	6
Young Adults Placebo	2	2

Primary outcome: Number of Participants Who Report an Adverse Event (AE)

Time frame: Up to Day 14. Count of participants. Unit: Participants

Measure	Adolescents Odanacatib 10 mg n = 5	Adolescents Odanacatib 50 mg n = 3	Adolescents Placebo n = 3	Young Adults Odanacatib 50 mg n = 6	Young Adults Placebo n = 2
Value	1	0	0	1	0

Population analysed: The population analyzed consisted of all randomized participants who received at least 1 dose of study drug.

Primary outcome: 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

Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: μM·hr

Measure	Adolescents Odanacatib 10 mg n = 0	Adolescents Odanacatib 50 mg n = 3	Adolescents Placebo n = 0	Young Adults Odanacatib 50 mg n = 6	Young Adults Placebo n = 0
Value	–	21.6 (30.7)	–	27.2 (40.4)	–

Population analysed: 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.

Primary outcome: 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

Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: μM·hr

Measure	Adolescents Odanacatib 10 mg n = 0	Adolescents Odanacatib 50 mg n = 3	Adolescents Placebo n = 0	Young Adults Odanacatib 50 mg n = 6	Young Adults Placebo n = 0
Value	–	18.7 (24.0)	–	21.5 (39.8)	–

Population analysed: 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.

Primary outcome: Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg

Time frame: Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: nM

Measure	Adolescents Odanacatib 10 mg n = 0	Adolescents Odanacatib 50 mg n = 3	Adolescents Placebo n = 0	Young Adults Odanacatib 50 mg n = 6	Young Adults Placebo n = 0
Value	–	256 (30.8)	–	237 (51.1)	–

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Day 14 (MK-0822-066) & Up to 408 hours post-dose (historical study MK-0822-007). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adolescents Odanacatib 10 mg	0 of 5 (0%)	1 of 5 (20%)	Not reported
Adolescents Odanacatib 50 mg	0 of 3 (0%)	0 of 3 (0%)	Not reported
Adolescents Placebo	0 of 3 (0%)	0 of 3 (0%)	Not reported
Young Adults Odanacatib 50 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Young Adults Placebo	0 of 2 (0%)	0 of 2 (0%)	Not reported
Young Adults Odanacatib 10 mg	0 of 12 (0%)	2 of 12 (16.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Odanacatib in people with Osteoporosis, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Report an Adverse Event (AE) (time frame: Up to Day 14). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01630616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.