A Phase 1 interventional study of MK-0822 in Hepatic Insufficiency, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of MK-0822. The primary hypothesis is that plasma AUC0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.
325 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.
This study's enrollment of 17 is below the median of 36 across 220 interventional studies indexed under Hepatic Insufficiency.
Browse Hepatic Insufficiency studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Single-dose administration of odanacatib 50 mg to participants with moderate hepatic insufficiency.
Drug: MK-0822
Single-dose administration of odanacatib 50 mg to healthy matched control participants.
Drug: MK-0822
A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.
Also known as: odanacatib
Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Maximum Concentration (Cmax) of MK-0822 After Single Dose
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose
Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.
Time frame: Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose
| Milestone | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group |
|---|---|---|
| Started | 8 | 9 |
| Completed | 8 | 8 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.
| μM*hr | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group |
|---|---|---|
| Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose | 28.84 (21.88 to 38.01) | 33.79 (25.64 to 44.54) |
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.
| nM | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group |
|---|---|---|
| Maximum Concentration (Cmax) of MK-0822 After Single Dose | 199.41 (150.26 to 264.64) | 279.59 (210.68 to 371.05) |
For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.
| hr | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group |
|---|---|---|
| Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose | 4.00 (2.00 to 48.00) | 24.00 (2.00 to 48.00) |
Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.
| hr | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group |
|---|---|---|
| Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose | 91.5 ± 30.1 | 70.5 ± 10.2 |
Collected over Up to 15 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Moderate Hepatic Insufficiency Group | — | 0/8 (0%) | 1/8 (12.5%) |
| Healthy Matched Control Group | — | 0/9 (0%) | 1/9 (11.1%) |
| Event | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group |
|---|---|---|
| NasopharynigitisInfections and infestations | 1/8 | 0/9 |
| HeadacheNervous system disorders | 0/8 | 1/9 |
| Age, Continuous(years) | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group | Total |
|---|---|---|---|
| Mean | 53.1 ± 4.9 | 54.2 ± 5.3 | 53.7 ± 5.0 |
| Sex: Female, Male(Participants) | Moderate Hepatic Insufficiency Group | Healthy Matched Control Group | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 7 | 8 | 15 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
No publications or documents are linked to this record.
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Merck Sharp & Dohme LLC