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

NCT02104648 | Completed Phase 1

• 1 other identifier: BP29269
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• Part A: Incidence of adverse events

  Up to 30 days

• Part B: Continuous, 12-lead, Holter electrocardiogram (ECG) recordings

  Days -1 (screening) to 11

Secondary Outcomes (1)

• Parts A & B: Area under the concentration-time curve (AUC) of RO4602522

  Days 1 to 10

Study Arms (5)

Part A: Placebo

PLACEBO COMPARATOR

Other: Placebo RO4602522

Part A: RO4602522

EXPERIMENTAL

Drug: RO4602522

Part B: RO4602522 Multiple Doses

EXPERIMENTAL

Drug: RO4602522; Other: moxifloxacin placebo

Part B: RO4602522 Single Dose

EXPERIMENTAL

Other: Placebo RO4602522; Drug: RO4602522; Other: moxifloxacin placebo

Part B: moxifloxacin Single Dose

EXPERIMENTAL

Other: Placebo RO4602522; Drug: moxifloxacin

Interventions

Placebo RO4602522 OTHER

Daily oral doses

Part A: Placebo; Part B: RO4602522 Single Dose; Part B: moxifloxacin Single Dose

RO4602522 DRUG

Daily oral doses

Part A: RO4602522; Part B: RO4602522 Multiple Doses

moxifloxacin DRUG

400 mg oral dose given on Day 1 or 11

Part B: moxifloxacin Single Dose

moxifloxacin placebo OTHER

Dose given orally on Days 1 and/or 11

Part B: RO4602522 Multiple Doses; Part B: RO4602522 Single Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

sembragiline; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)