A Phase 1 interventional study of MK-0524A and MK-0524A in Hypercholesterolemia, Familial and Heterozygous Familial Hypercholesterolemia, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 10 Years to 16 Years. Per ClinicalTrials.gov, last updated 2015-11-03.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
The purpose of this study is to determine the pharmacokinetics of laropiprant following administration of a single dose of 1 (Panel A) and 2 (Panel B) combination tablets of MK-0524A in adolescents with heterozygous familial hypercholesterolemia.
245 studies on the registry are indexed under Hyperlipoproteinemia Type II; 52 are open to participants now.
This study's enrollment of 10 is below the median of 86 across 170 interventional studies indexed under Hyperlipoproteinemia Type II.
Browse Hyperlipoproteinemia Type II 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Drug: MK-0524A
Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
Drug: MK-0524A
1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally
Also known as: Extended-release (ER) Niacin/Laropiprant
2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally
Also known as: Extended-release (ER) Niacin/Laropiprant
Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant
Time frame: Predose Day 1 up to 24 hours postdose
Plasma Maximum Concentration (Cmax) of Laropiprant
Time frame: Predose on Day 1 up to 48 hours postdose
Total Urinary Excretion of Niacin and Niacin Metabolites
Time frame: Predose on Day 1 up to 72 hours postdose
Plasma Cmax of Nicotinuric Acid (NUA)
Time frame: Predose on Day 1 up to 48 hours postdose
| Milestone | MK-0524A 1 g/20 mg (Panel A) | MK-0524A 2 g/40 mg (Panel B) |
|---|---|---|
| Started | 10 | 0 |
| Completed | 10 | 0 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over up to 14 days for each panel. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MK-0524A 1 g/20 mg (Panel A) | — | 0/10 (0%) | 7/10 (70%) |
| MK-0524A 2 g/40 mg (Panel B) | — | — | — |
| Event | MK-0524A 1 g/20 mg (Panel A) | MK-0524A 2 g/40 mg (Panel B) |
|---|---|---|
| HeadacheNervous system disorders | 2/10 | — |
| Abdominal pain lowerGastrointestinal disorders | 1/10 | — |
| Bruising of armInjury, poisoning and procedural complications | 1/10 | — |
| SprainInjury, poisoning and procedural complications | 1/10 | — |
| Low back painMusculoskeletal and connective tissue disorders | 1/10 | — |
| DiuresisRenal and urinary disorders | 1/10 | — |
| PruritusSkin and subcutaneous tissue disorders | 1/10 | — |
| Facial flushingVascular disorders | 1/10 | — |
| FlushingVascular disorders | 1/10 | — |
| Age, Continuous(Years) | MK-0524A 1 g/20 mg (Panel A) |
|---|---|
| Mean | 15.4 ± 0.8 |
| Sex: Female, Male(Participants) | MK-0524A 1 g/20 mg (Panel A) |
|---|---|
| Female | 5 |
| Male | 5 |
No study locations are listed for this record.
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC