Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104648
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Other: Placebo RO4602522 Drug: RO4602522 Drug: moxifloxacin Other: moxifloxacin placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Placebo Comparator: Part A: Placebo Other: Placebo RO4602522
Daily oral doses

Experimental: Part A: RO4602522 Drug: RO4602522
Daily oral doses

Experimental: Part B: RO4602522 Multiple Doses Drug: RO4602522
Daily oral doses

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

Experimental: Part B: RO4602522 Single Dose Other: Placebo RO4602522
Daily oral doses

Drug: RO4602522
Single, oral dose

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

Experimental: Part B: moxifloxacin Single Dose Other: Placebo RO4602522
Daily oral doses

Drug: moxifloxacin
400 mg oral dose given on Day 1 or 11




Primary Outcome Measures :
  1. Part A: Incidence of adverse events [ Time Frame: Up to 30 days ]
  2. Part B: Continuous, 12-lead, Holter electrocardiogram (ECG) recordings [ Time Frame: Days -1 (screening) to 11 ]

Secondary Outcome Measures :
  1. Parts A & B: Area under the concentration-time curve (AUC) of RO4602522 [ Time Frame: Days 1 to 10 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104648


Locations
Layout table for location information
United States, Kansas
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02104648     History of Changes
Other Study ID Numbers: BP29269
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs