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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Patient Study

Treatments: Drug: RG1662; Drug: itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02470832

WP29402

2015-000261-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Combination therapy RG1662 + itraconazole

Experimental group

Description:

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

Treatment:

Drug: itraconazole

Drug: RG1662

RG1662 Monotherapy

Experimental group

Description:

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.)

Treatment:

Drug: RG1662

itraconazole Monotherapy

Experimental group

Description:

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

Treatment:

Drug: itraconazole