Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03758339
Other study ID # ONT-380-008
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 30, 2017
Est. completion date January 30, 2018

Study information

Verified date November 2018
Source Seattle Genetics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib while it is still in the body. Healthy participants will get one dose of tucatinib by mouth. Patients will be monitored for 8-14 days after they take the dose of tucatinib.


Description:

This study will examine the absorption, metabolism, and excretion of tucatinib in healthy individuals. Participants will receive one oral dose of tucatinib and will be followed for 8-14 days after the dose is received.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date January 30, 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, or lab evaluations

- Body mass index (BMI) between 18 and 32 kg/m²

- Weight between 50 and 100 kg

- Females must be of non-childbearing potential

- Males must agree to use contraception

Exclusion Criteria:

- History of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder

- Any condition affecting drug absorption

- History of hypersensitivity or allergy to any drug compound, food, or other substance

- History of alcoholism or drug/chemical abuse within 2 years

- Use of prescription products within 28 days prior to check in

- Use of tobacco- or nicotine-containing products within 3 months prior to check in

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
tucatinib
Single dose of 300 mg of [¹4C]-tucatinib containing approximately 150 µCi of [¹4C] radioactivity

Locations

Country Name City State
United States Covance Clinical Research Unit Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Cascadian Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf]) PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles Up to 14 days
Primary AUC from time 0 to last quantifiable concentration PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles Up to 14 days
Primary Maximum observed concentration PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles Up to 14 days
Primary Time of maximum observed concentration PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles Up to 14 days
Primary Apparent terminal elimination half-life PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles Up to 14 days
Primary Apparent total clearance PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles Up to 14 days
Primary Apparent volume of distribution PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles Up to 14 days
Primary AUC[0-inf] plasma tucatinib/total radioactivity ratio AUC[0-inf] of plasma tucatinib relative to AUC[0-inf] of plasma total radioactivity Up to 14 days
Primary AUC[0-inf] blood/plasma ratio AUC[0-inf] of whole blood total radioactivity to AUC[0-inf] of plasma total radioactivity Up to 14 days
Primary Amount excreted in urine (Aeu) PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections Up to 14 days
Primary Cumulative Aeu PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections Up to 14 days
Primary Percentage excreted in urine (Feu) PK outcome endpoint of tucatinib and total radioactivity derived from urine collections Up to 14 days
Primary Cumulative Feu PK outcome endpoint of tucatinib and total radioactivity derived from urine collections Up 14 days
Primary Renal clearance PK outcome endpoint of tucatinib derived from urine collections Up to 14 days
Primary Amount excreted in feces [Aef] PK outcome endpoint of total radioactivity derived from feces collection Up to 14 days
Primary Cumulative Aef PK outcome endpoint of total radioactivity derived from feces collection Up to 14 days
Primary Percentage excreted in feces [Fef] PK outcome endpoint of total radioactivity derived from feces collection Up to 14 days
Primary Cumulative Fef PK outcome endpoint of total radioactivity derived from feces collection Up to 14 days
Secondary Relative abundance of tucatinib and its metabolites eliminated in urine and feces Up to 14 days
Secondary Relative abundance of tucatinib and its metabolites in plasma Up to 14 days
Secondary Incidence of adverse events (AEs) Up to 14 days
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1