Status:
COMPLETED
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin
Lead Sponsor:
Seagen Inc.
Conditions:
Drug-drug Interaction
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin. This...
Detailed Description
This is a single center, fixed-sequence, drug-drug interaction study to assess the effects of multiple oral doses of tucatinib on the pharmacokinetics of a single oral dose of metformin in healthy sub...
Eligibility Criteria
Inclusion
- Healthy status, as defined by the absence of evidence of any clinically significant findings
- Males must agree to use a barrier method of birth control and not donate sperm during study plus 30 days after last dose of study drug
- Weight of ≥60kg
- Body mass index between 18.0 and 32.0 kg/m² (inclusive)
- Ability to abstain from alcohol-, caffeine-, and xanthine-containing food and beverages from 48 hours prior to admission through study discharge
- All nonregular medication (including over-the-counter medication, health supplements, and herbal remedies) must be stopped at least 28 days prior to admission
Exclusion
- Females who are of childbearing potential or lactating
- Males with female partners who are pregnant, lactating, or planning to become pregnant within 30 days of the study
- Use of any investigational drug or device within 30 days of study start
- Use of tobacco products within 21 days prior to admission
- Routine or chronic use of more than 3 grams of acetaminophen daily
- Strenuous activity, sunbathing, and contact sports within 72 hours prior to first admission and for the duration of the study
- Blood transfusion within 90 days of study drug administration
- History of alcoholism or drug abuse within 2 years
- History of alcohol consumption exceeding 7 drinks/week for female participants or 14 drinks/week for male subjects
- History of donation of more than 450 mL of blood within 60 days prior to dosing, or planned donation before 30 days have elapsed since intake of study drug
- Plasma or platelet donation within 7 days of initial study drug administration
- Positive screening test for Hepatitis B, Hepatitis C, or HIV 1 or 2 (human immunodeficiency virus)
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
- Renal disease or dysfunction as suggested by serum creatinine levels or abnormal creatinine clearance
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03826602
Start Date
February 12 2019
End Date
March 15 2019
Last Update
March 27 2019
Active Locations (1)
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1
Pharmaceutical Research Associates
Salt Lake City, Utah, United States, 84107