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

Healthy Volunteer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342925
• Other study ID #: WP29394
• Secondary ID: 2014-001851-21
• Status: Completed
• Phase: Phase 1
• First received: January 7, 2015
• Last updated: November 1, 2016
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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
• metformin
Single 850 mg dose of metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Pharmacodynamics: renal function measured by derivation of glomerular filtration rate (GFR) from plasma concentrations of iohexol.		Up to 9 weeks	No
Secondary	Incidence of adverse events (AEs)		Up to 9 weeks	No