A Drug Interaction Study of Albiglutide and Digoxin

NCT01147718 | Completed Phase 1 DMC

• 1 other identifier: 111680
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.

Conditions

Diabetes Mellitus, Type 2

Keywords

pharmacokinetics; albiglutide; Healthy volunteer; digoxin

Outcome Measures

Primary Outcomes (1)

• The pharmacokinetic parameters of digoxin with and without albiglutide

  38 days

Secondary Outcomes (1)

• Safety of digoxin with and without albiglutide

  38 days

Study Arms (1)

digoxin plus albiglutide

EXPERIMENTAL

A single dose of 0.5mg digoxin administered on Day 1 followed by 5 weekly subcutaneous injections of albiglutide, followed by a further single dose of 0.5mg digoxin on Day 38.

Biological: digoxin plus albiglutide

Interventions

digoxin plus albiglutide BIOLOGICAL

A single dose of 0.5mg digoxin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide, followed by a single dose of 0.5mg digoxin on Day 38.

digoxin plus albiglutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy volunteers
• female subjects must be of nonchildbearing potential
• no clinically significant diseases or clinically significant abnormal laboratory values
• body mass index (BMI) is \>/=18 kg and ≤30 kg/m2
• a nonsmoker

You may not qualify if:

• positive test results for hepatitis B, hepatitis C or human immunodeficiency virus
• female subject is pregnant or breast-feeding
• history of any anaphylactic reaction to any drug
• history of significant cardiovascular or pulmonary dysfunction
• current or chronic history of liver disease
• history of alcohol or substance abuse
• history of thyroid disease or dysfunction
• history of gastrointestinal surgery or disease
• history of pancreatitis
• history of cholecystitis or other gallbladder disease
• previously received any GLP-1 mimetic compound (e.g., exenatide)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

Related Publications (2)

• Bush M, Scott R, Watanalumlerd P, Zhi H, Lewis E. Effects of multiple doses of albiglutide on the pharmacokinetics, pharmacodynamics, and safety of digoxin, warfarin, or a low-dose oral contraceptive. Postgrad Med. 2012 Nov;124(6):55-72. doi: 10.3810/pgm.2012.11.2613.

  PMID: 23322139 BACKGROUND

• Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

  PMID: 25387217 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 111680 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Digoxin; rGLP-1 protein

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: June 22, 2010
• Study Start: June 11, 2010
• Primary Completion: November 29, 2010
• Study Completion: November 29, 2010
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)