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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Other: Omnipaque 300; Drug: RG1662; Drug: metformin

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RG1662 plus metformin	Other: Omnipaque 300; 647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function; Drug: RG1662; Oral administration twice daily; Drug: metformin; Single 850 mg dose of metformin
Experimental: metformin alone	Other: Omnipaque 300; 647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function; Drug: metformin; Single 850 mg dose of metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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]	Up to 9 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	Up to 9 weeks
Pharmacokinetic parameters derived from plasma concentrations of RG1662: AUC, Cmax, time to maximum concentration (Tmax), and minimum concentration (Ctrough)[composite outcome measure]	Up to 9 weeks
Pharmacodynamics: renal function measured by derivation of glomerular filtration rate (GFR) from plasma concentrations of iohexol.	Up to 9 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 21, 2015

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: WP29394; 2014-001851-21 (EudraCT Number)