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A Study of RO5186582 Treatment on Cytochrome P450 (CYP) 3A4 Activity in Healthy Participants

NCT ID: NCT02254759

Last Updated: 2016-11-02

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

2014-10-31

Study Completion Date

2014-11-30

Brief Summary

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This is a non-randomized, open-label, five treatment, fixed sequence cross-over study to investigate the effect of RO5186582 treatment on CYP3A activity using midazolam as a probe CYP3A substrate, and also to assess the pharmacodynamic measures of brain electrical activity and sedation to explore the pharmacodynamic interaction between the gama-amino butyric acid (GABA)A negative allosteric modulator RO5186582 and the prototypical GABAA positive allosteric modulator midazolam. The anticipated study duration is up to nine weeks.

Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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IV Midazolam Alone

A single 1 milligram (mg) dose of IV Midazolam on Day 1.

Group Type OTHER

Midazolam, IV

Intervention Type DRUG

2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min).

Oral Midazolam Alone

A single 5 mg oral dose of midazolam on Day 2.

Group Type OTHER

Midazolam, oral

Intervention Type DRUG

0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam.

RO5186582 Alone

RO5186582 240 mg oral tablet twice daily (BID) for 14 days from Days 3 to 16.

Group Type EXPERIMENTAL

RO5186582

Intervention Type DRUG

RO5186582 120 mg film-coated release tablet.

RO5186582 Plus IV Midazolam

RO5186582 240 mg BID oral tablet in combination with a single 1 mg IV dose of midazolam on Day 17.

Group Type EXPERIMENTAL

Midazolam, IV

Intervention Type DRUG

2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min).

RO5186582

Intervention Type DRUG

RO5186582 120 mg film-coated release tablet.

RO5186582 Plus Oral Midazolam

RO5186582 240 mg BID in combination with a single 5 mg oral dose of midazolam on Day 18.

Group Type EXPERIMENTAL

Midazolam, oral

Intervention Type DRUG

0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam.

RO5186582

Intervention Type DRUG

RO5186582 120 mg film-coated release tablet.

Interventions

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Midazolam, IV

2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min).

Intervention Type DRUG

Midazolam, oral

0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam.

Intervention Type DRUG

RO5186582

RO5186582 120 mg film-coated release tablet.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy participants with signed informed consent.

Exclusion Criteria

* A history of epilepsy, convulsions or significant head injury
* 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, including herbal treatments such as St John's Wort, 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

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Leeds, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2014-001850-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WP29393

Identifier Type: -

Identifier Source: org_study_id