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

NCT02470832 | Completed Phase 1

• 2 other identifiers: WP294022015-000261-31
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Patient Study

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change from baseline in QTcF

  Up to 29 days

• Incidence of adverse events

  Within 43 days

• Clinically significant changes from baseline in physical examination or laboratory parameters

  Within 29 days

• Mean model parameters of RG1662 concentration vs. QTcF changes

  Within 29 days

Study Arms (3)

Combination therapy RG1662 + itraconazole

EXPERIMENTAL

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

Drug: RG1662; Drug: itraconazole

RG1662 Monotherapy

EXPERIMENTAL

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.)

Drug: RG1662

itraconazole Monotherapy

EXPERIMENTAL

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

Drug: itraconazole

Interventions

RG1662 DRUG

Combination therapy RG1662 + itraconazole; RG1662 Monotherapy

itraconazole DRUG

Combination therapy RG1662 + itraconazole; itraconazole Monotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: June 12, 2015
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

GB (1)