- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03826602
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin
March 25, 2019 updated by: Seagen Inc.
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Tucatinib of the Pharmacokinetics of Metformin in Healthy Male and Female Subjects
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 will help us find out whether tucatinib is safe to give together with metformin.
The study will also look at how tucatinib affects how the kidneys work.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 subjects.
The primary objective of the study is to assess the effects of tucatinib on the single-dose PK of metformin.
Secondary objectives of the study are to (1) assess the safety and tolerability of metformin when coadministered with tucatinib and (2) assess the effects of tucatinib on renal function using iohexol as glomerular filtration rate (GFR) marker.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- Pharmaceutical Research Associates
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tucatinib plus metformin
Tucatinib administered twice daily on Days 2-8.
Metformin administered as a single dose on Days 1 and 8. Iohexol administered via IV push on Days 1 and 8
|
150mg administered orally twice daily
850mg administered orally
1500 mg administered intravenously (IV)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration (Cmax) of metformin
Time Frame: Up to 9 days
|
Up to 9 days
|
Time to maximum observed plasma concentration (tmax) of metformin
Time Frame: Up to 9 days
|
Up to 9 days
|
Half-life (t1/2) of metformin
Time Frame: Up to 9 days
|
Up to 9 days
|
Area under the plasma concentration-time curve from time 0 to the last available measurement (AUC0-last) of metformin
Time Frame: Up to 9 days
|
Up to 9 days
|
Area under the plasma concentration time curve to time 0 extrapolated to infinity (AUC0-inf) of metformin
Time Frame: Up to 9 days
|
Up to 9 days
|
Apparent volume of distribution (V2/F) of metformin
Time Frame: Up to 9 days
|
Up to 9 days
|
Oral clearance (CL/F) of metformin
Time Frame: Up to 9 days
|
Up to 9 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events (as assessed by AE assessments, clinical laboratory tests, physical examinations, vital signs measurements, and 12-lead electrocardiogram)
Time Frame: Up to 16 days
|
Up to 16 days
|
Glomerular Filtration Rate (GFR) as measured by iohexol plasma clearance
Time Frame: Up to 8 days
|
Up to 8 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2019
Primary Completion (Actual)
March 8, 2019
Study Completion (Actual)
March 15, 2019
Study Registration Dates
First Submitted
January 30, 2019
First Submitted That Met QC Criteria
January 30, 2019
First Posted (Actual)
February 1, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SGNTUC-020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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