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NCT Number: NCT01147692

A Drug Interaction Study of Simvastatin and Albiglutide

This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Austin, Texas, 78744, United States

About this study

This Phase I open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • no clinically significant diseases or clinically significant abnormal laboratory values
  • females must be of non-childbearing potential
  • body mass index (BMI) is >/=18 kg and ≤30 kg/m2
  • nonsmoker
  • negative drug screen

Exclusion criteria

  • positive test results for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
  • any clinically relevant abnormality
  • 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 dysfunction or disease
  • history of gastrointestinal surgery or disease
  • history of pancreatitis
  • previously received any GLP-1 mimetic compound (e.g., exenatide)

Treatment and study plan

simvastatin plus albiglutide

Biological

A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.

Primary outcomes

  1. The effect of albiglutide on the pharmacokinetics of simvastatin

    Time frame: 42 days

Secondary outcomes

  1. The pertinent plasma pharmacokinetic parameters of simvastatin with and without albiglutide

    Time frame: 42 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2010
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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