NCT01583647

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 4, 2013

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

April 20, 2012

Results QC Date

October 7, 2013

Last Update Submit

November 2, 2015

Conditions

Hypercholesterolemia, FamilialHeterozygous Familial Hypercholesterolemia

Outcome Measures

Primary Outcomes (4)

  • Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant

    Predose Day 1 up to 24 hours postdose

  • Plasma Maximum Concentration (Cmax) of Laropiprant

    Predose on Day 1 up to 48 hours postdose

  • Total Urinary Excretion of Niacin and Niacin Metabolites

    Predose on Day 1 up to 72 hours postdose

  • Plasma Cmax of Nicotinuric Acid (NUA)

    Predose on Day 1 up to 48 hours postdose

Study Arms (2)

MK-0524A 1 g/20 mg (Panel A)

EXPERIMENTAL

Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg

Drug: MK-0524A

MK-0524A 2 g/40 mg (Panel B)

EXPERIMENTAL

Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg

Drug: MK-0524A

Interventions

MK-0524ADRUG

1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally

Also known as: Extended-release (ER) Niacin/Laropiprant
MK-0524A 1 g/20 mg (Panel A)

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Post-pubescent adolescent age 10 to 16 with heterozygous familial hypercholesterolemia
  • Agree to use (and/or have their partner use) acceptable methods of birth control beginning at the prestudy visit until at least 2 weeks after dosing of study drug
  • Height and weight fall between the 10th and 95th percentile for age with a minimum body weight of 23 kg
  • Receiving appropriate medical care for hypercholesterolemia, such as a statin or other lipid-modifying therapy.

You may not qualify if:

  • History of psychiatric or personality disorders that may affect the patient's ability to participate
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases (excluding lipid abnormalities)
  • Poorly controlled or recently diagnosed Type 1 or Type 2 diabetes mellitus
  • History of neoplastic disease within previous 5 years
  • Consumes alcohol or excessive amounts of products that contain caffeine (e.g. cola)
  • Has had major surgery, donated and/or received blood within previous 8 weeks
  • Participated in another investigational study within previous 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
  • Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
  • Cannot swallow large tablets
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

NiacinMK-0524

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 24, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 3, 2015

Results First Posted

December 4, 2013

Record last verified: 2015-11