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Completed

NCT Number: NCT01376063

Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the plasma pharmacokinetic of rosiglitazone in healthy adult subjects.

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Key information

Conditions

Healthy Adult Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adult males, 18 to 45 years
  • Body weight ≥ 75 kg
  • Good health
  • Non-smoker
  • Blood pressure not greater than 140/90 mm Hg

Exclusion criteria

  • Positive for any of the following: Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
  • Blood donation or significant blood loss within 60 days prior to Day 1
  • Use of prescription and over the counter medications/herbal preparations is not allowed within 14 days prior to Day 1 and through treatment phase
  • History or presence of alcoholism or drug abuse within 2 years prior to Day 1
  • Consumption of alcohol within 7 days prior to Day 1 or during treatment phase
  • Positive urine drug/alcohol testing at screening or check-in visit

Treatment and study plan

FG-4592

Drug

FG-4592 on days 3,5,7,9

Rosiglitazone maleate on days 1 and 9

Primary outcomes

  1. Change in plasma concentration of Rosiglitazone

    Time frame: Day 1- Day 11

Secondary outcomes

  1. Change in plasma concentration of Rosiglitazone metabolites

    Time frame: Day 3 - Day 11

Sponsors and collaborators

Lead sponsor

Kyntra Bio

Industry

Registry information

Official study title

A Phase 1, Single-Center, One-Sequence, Open-Label Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 20, 2011
Registry last updated
Jun 20, 2011

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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