A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Sitagliptin phosphate (Drug); Comparator: matching placebo (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to
17 year old diabetic patients.
Clinical Details
Official title: A Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Sitagliptin in Adolescents
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Participants Who Experienced at Least One Adverse EventArea Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin
Secondary outcome: Maximum Concentration (Cmax) Following a Single Dose of SitagliptinTime of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo
Eligibility
Minimum age: 10 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males or females who are 10 - 17 years of age
- History of type 2 diabetes
- Nonsmoker
- No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes
Exclusion Criteria:
- History of diabetic ketoacidosis
- History of stroke, chronic seizures or major neurological disorder
- Consumes alcohol
- Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of
caffeine) of coffee, tea, cola or other beverages containing caffeine per day
- Unable to swallow tablets
- Has had surgery, donated or lost 1 unit of blood, or participated in another
investigational study within a minimum of 4 weeks prior to starting the study
- History of multiple and/or severe allergies or has had an allergic reaction to or
significant intolerability to prescription or non-prescription drugs or food
- Currently a regular user of any illicit drugs or has a history of drug or alcohol
abuse
- History of clinically significant endocrine, gastrointestinal,
cardiovascular, hematological, hepatic, immunological, renal, respiratory, or
genitourinary abnormalities or diseases
- Has an estimated creatinine clearance of less than or equal to 80 mL/min
Locations and Contacts
Additional Information
Starting date: July 2008
Last updated: August 7, 2015
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