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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02342925

Enrollment

Registered

2015-01-21

Start date

2015-02-28

Completion date

2015-05-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

OTHEROmnipaque 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

DRUGRG1662

Oral administration twice daily

DRUGmetformin

Single 850 mg dose of metformin

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Measure	Time frame
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
Incidence of adverse events (AEs)	Up to 9 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026