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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Patient Study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination therapy RG1662 + itraconazole

Days 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food

Group Type EXPERIMENTAL

RG1662

Intervention Type DRUG

itraconazole

Intervention Type DRUG

RG1662 Monotherapy

Days 1-10: RG1662 120 mg twice daily (b.i.d.) within 30 minutes of a meal for 10 days (Days 1 to 9, Day 10 only a.m. dose). (Cohort A subjects will receive 1 x 120 mg RG1662 tablets twice daily. In Cohorts B and C the dose of RG1662 will be decided upon following review of the interim safety and pharmacokinetic data of the 4 subjects in Cohort A.)

Group Type EXPERIMENTAL

RG1662

Intervention Type DRUG

itraconazole Monotherapy

Days 15-19: 200 mg of itraconazole twice daily for 5 days (Days 15 to 18, Day 19 only a.m. dose)

Group Type EXPERIMENTAL

itraconazole

Intervention Type DRUG

Interventions

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RG1662

Intervention Type DRUG

itraconazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes