Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to determine the pharmacokinetic and safety profile of alogliptin in children, adolescents, and adults with type 2 diabetes mellitus.

Key facts

Study ID

NCT00957268

Run by

Takeda

People needed

46

Starts

2009-09-01

Expected to finish

2013-11-01

Last updated by the study team

2015-01-29

Who can join

Age: 10 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Participant was currently participating in another investigational study or took an investigational drug within 30 days prior to Day 1.
• Participant received alogliptin previously.
• Participant was a study site employee, or was an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
• Participant received or donated blood or blood products within 30 days prior to Screening or planned to donate blood during the study.
• Participant had a known hypersensitivity to alogliptin or related compounds.
• Participant had a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as consumption of more than 4 alcoholic drinks per day) within 1 year prior to study Day 1.
• Participant had an acute, clinically significant illness (excluding T2DM) within 30 days prior to study Day 1.
• Participant had any other condition or prior therapy that, in the opinion of the investigator, would have made the participant unsuitable for the study.
• Participant had a history or clinical manifestations of significant metabolic (excluding T2DM), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, musculoskeletal, or psychiatric disorder.
• Participant had a hemoglobin value < 12 g/dL.
• Participant had a systolic blood pressure > 140 mm Hg or had a diastolic blood pressure > 90 mmHg at Screening or Check-in (Day -1).
• Adult participant had an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level greater than 2 times the upper limit of normal (ULN), active liver disease, or jaundice at the Screening Visit or on Check-in (Day -1).
• Pediatric participant had an ALT or AST level greater than 1.5 times the ULN at the Screening Visit or on Check-in (Day -1).
• Participant had a serum creatinine level > 1.5 mg/dL.
• Participant had a creatinine clearance (CrCl) < 50 mL/min (normalized to body surface area of 1.73 m\^2).
• Participant had a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy) or thoracic or nonperipheral vascular surgery within 6 months prior to Day 1.
• Participant had a history or presence of a clinically significant abnormal 12-lead electrocardiogram (ECG) result as determined by the investigator or Takeda at Screening or Check-in (Day -1).
• Participant had a history of cancer, other than basal cell carcinoma or Stage I squamous cell carcinoma of the skin that had not been in remission for at least 5 years prior to the first dose of study drug.
• If female, participant was pregnant or lactating or intending to become pregnant before, during, or within 30 days after receiving study drug.
• If male, participant intended to impregnate others during the study or for 30 days after receiving study drug.
• Participant consumed or was unable to abstain from consumption of products containing alcohol, caffeine, or xanthine, and food or beverages containing grapefruit juice or Seville-type oranges within 72 hours prior to study Day 1 and for the duration of the study.
• Participant used any tobacco (ie, nicotine) products (including but not limited to cigarettes, pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum) within 6 weeks prior to study Day 1, and was unwilling to abstain from these products for the duration of the study.
• Participant used any nutraceutical preparations within 28 days prior to study Day 1.
• Participant was currently taking ketoconazole, fluconazole, gemfibrozil, rifampin, or carbamazepine or taken within 28 days prior to Check-in (Day -1).
• Participant had poor peripheral venous access.

Where it is running

• Study site — Miami, Florida, United States
• Study site — Pineallas Park, Florida, United States
• Study site — Louisville, Kentucky, United States
• Study site — Durham, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Memphis, Tennessee, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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