Comparison of Pediatric Formulation (liquid) to Adult Formulation(tablets)

• Conditions: Vorapaxar is indicated for the reduction of thrombotic cardiovascularevents in patients with a history of myocardial infarction (MI) or withperipheralarterial disease (PAD).; MedDRA version: 17.1Level: LLTClassification code 10014501Term: Embolism - blood clotSystem Organ Class: 100000004866; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004350-34-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-29
• Last Update Posted: 3 November 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1) Healthy, non-smoking, male and female subjects, from 18 to 55
years of age.
2) BMI = 19.0 and =30.0 kg/m2 and weight =60 kg.
3) No clinically significant findings in vital-signs measurements.
4) No clinically significant abnormal laboratory values.
5) No clinically significant findings in a 12-lead electrocardiogram
(ECG).
6) Have no significant diseases.
7) Willing to use an acceptable, effective method of contraception.
8) Be informed of the nature of the study and give written consent
prior to any study procedure.
9) Have no clinically significant findings from a physical examination.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Known history or presence of any clinically significant medical
condition.
2) Known or suspected carcinoma.
3) History of stroke, myocardial infarction (MI), transient ischemic
attack (TIA), peripheral arterial disease (PAD) or intracranial
hemorrhage (ICH).
4) Known history or presence of active clinically
significant/pathological bleeding (e.g., peptic ulcer, intracranial
hemorrhage, clotting disorders).
5) Known history or presence of galactose or fructose intolerance,
sucrase-isomaltase insufficiency, Lapp lactase insufficiency,
galactosemia, or glucose-galactose malabsorption syndrome.
6) Subjects with mouth piercings, dentures, braces, dental appliances,
or any other alteration to the mouth that may compromise drug
delivery.
9) Presence of clinically significant gastrointestinal disease or history
of malabsorption within the last year.
10) Presence of a medical condition requiring regular medication
(prescription and/or over-the-counter) with systemic absorption.
11) History of drug or alcohol addiction requiring treatment.
12) Positive test result for HIV, Hepatitis B surface antigen or Hepatitis
C antibody.
13) Positive test result for urine drugs of abuse (cannabinoids, opiates,
amphetamines, cocaine, phencyclidine, tricyclic antidepressants,
barbiturates, methadone and benzodiazepines) or urine cotinine.
14) Difficulty fasting or consuming standard meals.
15) Does not tolerate venipuncture.
16) Use of tobacco or nicotine-containing products within 6 months
prior to drug administration.
17) On a special diet within 30 days prior to drug administration (e.g.,
liquid, protein, raw food diet).
18) Participated in a clinical trial, which involved administration of an
investigational medicinal product within 30 days prior to drug
administration, or recently participated in a clinical investigation that,
in the opinion of the Investigator, would jeopardize subject safety or
the integrity of the study results.
19) Donation or loss of whole blood (including clinical trials):
• = 50 mL and = 499 mL within 30 days prior to drug administration;
• = 500 mL within 56 days prior to drug administration.
20) Females who:
• Have used oral or transdermal hormonal contraceptives within 21
days prior to drug administration;
• Have used implanted, injected, intravaginal or intrauterine hormonal
contraceptives within 6 months prior to drug administration;
• Are pregnant (serum hCG consistent with pregnancy); or
• Are lactating.
21) Have had a tattoo or body piercing within 30 days prior to drug
administration.
22) Estimated creatinine clearance of =80 mL/min based on the
Cockcroft-Gault equation.
23) Known history or presence of hypersensitivity or idiosyncratic
reaction to vorapaxar (MK-5348) or any other drug substances with
similar activity.
24) Subject is mentally or legally incapacitated, has significant
emotional problems at the time of screening or expected during the
conduct of the study or has a history of a clinically significant
psychiatric disorder over the last 5 years. Subjects who have had
situational depression may be enrolled in the study at the discretion of
the investigator.
25) Have planned a surgery or dental procedure within 30 days after drug administration.
26) Within 30 days prior to the drug administration, use of:
• antidepressants (e.g., SSRI [citalopram, fluoxetine], SNRI
[dexvenlafaxine, duloxetine]);
• antiplatelet, anticoagulants or fibrinolytics (e.g.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified