Effect of HM30181A on the Pharmacokinetics of Digoxi

Phase 1

Completed

• Conditions: Cancer; Cancer - Any cancer

• Registration Number: ACTRN12618000798268
• Lead Sponsor: Athenex Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-10
• Study Completion: 2018-12-17
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Males and females aged at least 18 years and up to 55 years on day of consent; Creatinine clearance >=80 mL/min; non-smoker; in good health; Body mass index (BMI) greater than or equal to 18.0 and <30.0 kg/m2 at Screening; willing to adhere to the alcohol and caffeine restrictions. Females must be postmenopausal or surgically sterile or must be using effective
contraception for at least 4 weeks prior to dosing and agree to continue use of
contraception for 30 days after their last dose.

Exclusion Criteria

A history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; an elevated prothrombin time (PT) or aPTT or platelet count below the lower limit of normal at Screening or Baseline; History of gastrointestinal bleeding, intracerebral bleeding or frequent nose-bleeds or active bleeding; prolonged QTc interval (QTc >450 ms), or PR interval >180ms or QRS interval >110ms on ECG at Screening; Heart rate <45bpm; Wolff-Parkinson-White syndrome; serum potassium or calcium concentration below the lower limit of normal; history of drug or alcohol abuse or dependence; taking any prescription drug or herbal medicine or supplement within 2 weeks or 5 half-lives prior to dosing, whichever is longer, or vitamin supplement within 1 week prior to dosing; clinically significant drug allergy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to determine the effect of multiple once-daily doses of HM30181A on the single-dose pharmacokinetics of digoxin.<br>The primary endpoint will be the ratio of the AUC0-8 of digoxin in the plasma after digoxin administration on Day 3 after HM30181A in Treatment Period 2 vs digoxin administration alone in Treatment Period 1.[Blood samples for determination of plasma concentrations of digoxin will be collected on: <br>Treatment Period 1: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96 and 120 hours, and Day 17 post-dose digoxin.<br>Treatment Period 2: Days 1, 2 and 3: predose HM30181A. Days 3-8: pre-dose digoxin and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96 and 120 hours, and Day 17 post-dose Day 3 digoxin<br><br>During Treatment Period 2, blood samples collected on Days 3-8 will also be used for determination of plasma concentrations of HM30181 and its M1 metabolite.]