MedDataX Logo

A 2-Part Study to Evaluate the Safety of Supra-Therapeutic Doses of RO4602522 and to Investigate the Effect of RO4602522 on the QTc Interval

NCT ID: NCT02104648

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized, double-blind, placebo-controlled study. Participants will be randomized to receive daily, oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control, parallel group study. Participants will be randomized to receive either multiple or single doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic parameters will be assessed for Parts A and B; and continuous ECG recordings will be made during Part B.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: Placebo

Group Type PLACEBO_COMPARATOR

Placebo RO4602522

Intervention Type OTHER

Daily oral doses

Part A: RO4602522

Group Type EXPERIMENTAL

RO4602522

Intervention Type DRUG

Daily oral doses

Part B: RO4602522 Multiple Doses

Group Type EXPERIMENTAL

RO4602522

Intervention Type DRUG

Daily oral doses

moxifloxacin placebo

Intervention Type OTHER

Dose given orally on Days 1 and/or 11

Part B: RO4602522 Single Dose

Group Type EXPERIMENTAL

Placebo RO4602522

Intervention Type OTHER

Daily oral doses

RO4602522

Intervention Type DRUG

Single, oral dose

moxifloxacin placebo

Intervention Type OTHER

Dose given orally on Days 1 and/or 11

Part B: moxifloxacin Single Dose

Group Type EXPERIMENTAL

Placebo RO4602522

Intervention Type OTHER

Daily oral doses

moxifloxacin

Intervention Type DRUG

400 mg oral dose given on Day 1 or 11

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo RO4602522

Daily oral doses

Intervention Type OTHER

RO4602522

Daily oral doses

Intervention Type DRUG

RO4602522

Single, oral dose

Intervention Type DRUG

moxifloxacin

400 mg oral dose given on Day 1 or 11

Intervention Type DRUG

moxifloxacin placebo

Dose given orally on Days 1 and/or 11

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and female subjects, 18 to 65 years of age, inclusive. For Part B: Healthy male and female subjects, 18 to 65 years of age, inclusive (female subjects only if the repeat dose is tolerated in Part A)
* Healthy status is defined by absence of evidence of any clinically significant, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
* A BMI between 18 to 32 kg/m2 inclusive
* Use of highly effective contraception

Exclusion Criteria

* Pregnant or breast-feeding women
* Suspicion of alcohol or drug abuse or positive drug screen
* Positive result on hepatitis B (HBsAg), hepatitis C (HCV), or HIV 1 and 2
* History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
* Diseases or medical conditions that are capable of altering the absorption, metabolism or elimination of drugs
* Any prescribed or over-the-counter medications (including vitamins or herbal remedies) taken within 2 weeks prior to first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer)
* Taking any nutrients known to modulate CYP3A activity (e.g., grapefruit juice; Seville orange) within 2 weeks prior to administration of study drugs or tyramine rich nutrients 48 hours prior to admission to study site and then throughout the study
* Participation in an investigational drug or device study within 60 days prior to screening or 5 times the elimination half-life of the medication prior to first dosing (whichever is longer)
* Consumption of nicotine and/ or tobacco products within the last 45 days prior to Day 1 of study

Part B

* Any clinically significant cardiovascular findings or history of such
* Allergy to moxifloxacin or any quinolone antibiotics or history of tendon rupture with quinolone-type antibiotic or any confirmed clinically significant allergic reactions against any drug, or multiple allergies in the judgment of the Investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lenexa, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BP29269

Identifier Type: -

Identifier Source: org_study_id