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A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826602
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

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 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.

Condition or disease Intervention/treatment Phase
Drug-drug Interaction Drug: Tucatinib Drug: Metformin Drug: Iohexol Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 12, 2019
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

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
Drug: Tucatinib
150mg administered orally twice daily

Drug: Metformin
850mg administered orally

Drug: Iohexol
1500 mg administered intravenously (IV)




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of metformin [ Time Frame: Up to 9 days ]
  2. Time to maximum observed plasma concentration (tmax) of metformin [ Time Frame: Up to 9 days ]
  3. Half-life (t1/2) of metformin [ Time Frame: Up to 9 days ]
  4. 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 ]
  5. Area under the plasma concentration time curve to time 0 extrapolated to infinity (AUC0-inf) of metformin [ Time Frame: Up to 9 days ]
  6. Apparent volume of distribution (V2/F) of metformin [ Time Frame: Up to 9 days ]
  7. Oral clearance (CL/F) of metformin [ Time Frame: Up to 9 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Glomerular Filtration Rate (GFR) as measured by iohexol plasma clearance [ Time Frame: Up to 8 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826602


Locations
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United States, Utah
Pharmaceutical Research Associates
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: JoAl Mayor, PharmD, BCOP Seattle Genetics, Inc.
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT03826602    
Other Study ID Numbers: SGNTUC-020
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs