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Completed

NCT Number: NCT02342925

A Study of the Effect of RG1662 on Metformin in Healthy Volunteers

This single-center, non-randomized, open-label, two treatment, two period, fixed sequence crossover study will investigate the effect of RG1662 treatment on the activity of key renal transporters in healthy male and female participants using metformin. The effect of RG1662 on other renal function parameters will also be explored.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female participants, aged 18 to 60 years, inclusive
  • A body mass index between 18 to 32 kg/m2, inclusive
  • Informed consent and agreement to comply with study restrictions

Exclusion criteria

  • A history of epilepsy, convulsions or significant head injury
  • Significant history of drug allergy or a known hypersensitivity to any of the ingredients of any of the study treatments
  • Pregnant or lactating
  • Impaired renal function or clinically relevant hematuria
  • A history of lactic acidosis, or risk factors for lactic acidosis
  • Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Treatment and study plan

Omnipaque 300

Other

647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function

RG1662

Drug

Oral administration twice daily

metformin

Drug

Single 850 mg dose of metformin

Primary outcomes

  1. Pharmacokinetic parameters of metformin derived from plasma and urine concentrations of metformin: area under the concentration-time curve (AUC), maximum concentration (Cmax), renal clearance (CLr) [composite outcome measure]

    Time frame: Up to 9 weeks

Secondary outcomes

  1. Pharmacokinetic parameters derived from plasma concentrations of RG1662: AUC, Cmax, time to maximum concentration (Tmax), and minimum concentration (Ctrough)[composite outcome measure]

    Time frame: Up to 9 weeks

  2. Pharmacodynamics: renal function measured by derivation of glomerular filtration rate (GFR) from plasma concentrations of iohexol.

    Time frame: Up to 9 weeks

  3. Incidence of adverse events (AEs)

    Time frame: Up to 9 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 21, 2015
Registry last updated
Nov 2, 2016

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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