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OpenTrials
Completed

NCT Number: NCT02470832

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

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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Key information

Conditions

Healthy Patient Study

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RG1662

Drug

Itraconazole

Drug

Primary outcomes

  1. Area under the plasma concentration-time curve from 0-t (AUC0-t)

    Time frame: Within 29 days

  2. Maximum observed plasma concentration (Cmax)

    Time frame: Within 29 days

  3. Time to maximum observed plasma concentration (Tmax)

    Time frame: Within 29 days

Secondary outcomes

  1. Change from baseline in QTcF

    Time frame: Up to 29 days

  2. Incidence of adverse events

    Time frame: Within 43 days

  3. Clinically significant changes from baseline in physical examination or laboratory parameters

    Time frame: Within 29 days

  4. Mean model parameters of RG1662 concentration vs. QTcF changes

    Time frame: Within 29 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2015
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.