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

Healthy Volunteer Clinical Trial

Official title:

A 2 PART STUDY IN HEALTHY SUBJECTS: PART A: A MULTIPLE DOSE, RANDOMIZED, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SUPRA-THERAPEUTIC DOSES OF RO4602522; PART B: A MULTIPLE-DOSE, RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PLACEBO CONTROLLED, POSITIVE-CONTROL, PARALLEL GROUP STUDY TO INVESTIGATE THE EFFECT OF RO4602522 ON THE QTC INTERVAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104648
• Other study ID #: BP29269
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2014
• Last updated: November 1, 2016
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Other:
• Placebo RO4602522
Daily oral doses

Drug:
• RO4602522
Daily oral doses
• RO4602522
Single, oral dose
• moxifloxacin
400 mg oral dose given on Day 1 or 11

Other:
• moxifloxacin placebo
Dose given orally on Days 1 and/or 11

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Incidence of adverse events		Up to 30 days	No
Primary	Part B: Continuous, 12-lead, Holter electrocardiogram (ECG) recordings		Days -1 (screening) to 11	No
Secondary	Parts A & B: Area under the concentration-time curve (AUC) of RO4602522		Days 1 to 10	No