A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02470832

Enrollment

Registered

2015-06-12

Start date

2015-05-31

Completion date

2015-07-31

Last updated

2016-08-26

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

Conditions

Healthy Patient Study

Brief summary

The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.

Interventions

DRUGRG1662

DRUGitraconazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female volunteers * Ages 18 to 60 years, inclusive * A body mass index (BMI) between 18 to 32 kg/m2, inclusive * Agreement to comply with study restrictions

Exclusion criteria

* History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities * Electrocardiogram (EGC) or vital signs abnormalities * Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments * Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration * Pregnant or lactating * Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration-time curve from 0-t (AUC0-t)	Within 29 days
Maximum observed plasma concentration (Cmax)	Within 29 days
Time to maximum observed plasma concentration (Tmax)	Within 29 days

Secondary

Measure	Time frame
Change from baseline in QTcF	Up to 29 days
Mean model parameters of RG1662 concentration vs. QTcF changes	Within 29 days
Incidence of adverse events	Within 43 days
Clinically significant changes from baseline in physical examination or laboratory parameters	Within 29 days

Countries

United Kingdom

Outcome results

None listed

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