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Healthy VolunteerPhase 1NCT02165332

A Two-part, Single-dose, Randomized Study to Evaluate the Safety of Supra-therapeutic Doses of RO7033877 and to Investigate the Effect of RO7033877 on the QTc Interval

A Phase 1 study testing Part 1: SAD RO7033877, Part 2: Treatment A, RO7033877 and Part 2: Treatment B, RO7033877 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy volunteers (Part 2). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Part 1: SAD RO7033877, Part 2: Treatment A, RO7033877 and Part 2: Treatment B, RO7033877
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteUnited States
Study dates
Jul 2014to Nov 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male or female of non-childbearing potential participants, 18 to 65 years of age, inclusive
  • Healthy status is defined as the absence of evidence of any clinically significant, active, or chronic disease following a detailed medical and surgical history, a complete physical examination and vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis and confirmed by a creatinine clearance estimated by formula of Cockcroft-Gault > 80 mL/min/1.73 m2
  • Postmenopausal or surgically sterile females (bilateral oophorectomy or hysterectomy performed at least 6 months prior to study participation)
  • A body mass index (BMI) between 18 and 30 kg/m2 inclusive and minimum body weight >/= 50 kg, inclusive
  • For men with a female partner(s) of childbearing potential: agreement to use a barrier method of contraception during the treatment period and for at least 3 months after the last dose of study drug
  • Participants who are non-smokers, or former smokers who have not smoked for at least 45 days prior to screening (former smokers are to have a total of < 10 pack year smoking history)

Who cannot join

  • Women of childbearing potential
  • Pregnant or lactating women
  • Men with female partners who are lactating or are pregnant
  • History of any clinically significant disease, e.g. gastrointestinal, renal, hepatic, cardiovascular, endocrine, hematologic or allergic disease(s), metabolic disorder, cancer (may have had basal or squamous cell carcinoma of skin or cervix as long as surgically removed or deemed cured by cryotherapy, laser therapy, conization, etc., with stability for the past 2 years)
  • Any major illness within one month before the first dose of study drug or any febrile illness within one week prior to screening and up to first dose administration
  • Any prescribed medications taken within 4 weeks prior to first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer)
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  • Any preparations containing St. John's Wort taken within 4 weeks prior to first dosing
  • Any other over-the-counter medications, including vitamins or herbal remedies, taken within 14 days prior to first dosing or within 5 times the elimination half-life of the medication prior to first dosing (whichever is longer); acetaminophen is the only exception
  • Taking any nutrients known to modulate cytochrome P450 (CYP) 3A activity. Participants will be instructed to abstain from consuming grapefruit, Seville oranges, and grapefruit- or Seville orange-containing products within 2 weeks prior to administration of study drugs
  • Regular consumption of large amounts of caffeine or xanthine-containing substances (e.g. >/= 5 cups of coffee/day, tea, cola, Mountain Dew, chocolate, diet pills, "energy drinks" or any other type of stimulant) or unable to refrain from consumption of caffeine or xanthine-containing substances from 72 hours prior to each entry in the clinic and during the in-house periods
  • Any medication that inhibits active tubular secretion (e.g. probenecid, H2 receptor antagonists, trimethoprim) within 4 weeks prior to first dosing
  • Participation in an investigational drug or device study within 60 days prior to screening
  • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • History and/or family history of cardiac anomalies, e.g. congenital long QT syndrome, unexplained syncope, or clinically significant abnormal ECG
  • ECG evidence at screening or baseline of, e.g. atrial fibrillation, atrial flutter, complete right or left bundle branch block and/or clinically relevant prolongation of the PR interval as determined by the Investigator
  • History of allergy or sensitivity to moxifloxacin or other fluoroquinolones, and/or history of tendon rupture when taking or considered time-wise related to consumption of a fluoroquinolone

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Study site

    Lenexa, Kansas, 66219

Other trials in United States

About this study

Official title: A Two-part, Single-center, Single-dose, Randomized, Double-blind, Double-dummy, Placebo-controlled, Positive-controlled, Four-way Crossover Study to Investigate the Effect of RO7033877 on the QT/QTc Interval in Healthy Subjects

This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind, placebo-controlled study to determine the safety tolerability and pharmacokinetics of a supratherapeutic dose to be used in Part 2. Participants will be randomized in up to 8 cohorts to receive a single dose of either RO7033877 or placebo. Part 2 will be a single dose, randomized, double-blind, double dummy, placebo-controlled, positive control, 4-way crossover study. Part 2 will evaluate whether a single therapeutic or supratherapeutic dose of RO7033877 has a threshold pharmacologic effect on cardiac repolarization, as detected by changes in the QT/QTc interval measured by electrocardiogram (ECG). Pharmacokinetic parameters will be assessed for Parts 1 and 2, continuous ECG recordings will be evaluated in Part 2.

Being tested
Part 1: SAD RO7033877, Part 1: SAD placebo, Part 2: Treatment A, RO7033877, Part 2: Treatment B, RO7033877, Part 2: Treatment C, moxifloxacin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Part 1: SAD RO7033877Drug

    Single dose

  • Part 1: SAD placeboDrug

    Single dose

  • Part 2: Treatment A, RO7033877Drug

    Single dose RO7033877 and moxifloxacin placebo

  • Part 2: Treatment B, RO7033877Drug

    Single dose RO7033877 and moxifloxacin placebo

  • Part 2: Treatment C, moxifloxacinDrug

    Single dose moxifloxacin and RO7033877 placebo

  • Part 2: Treatment D, RO7033877 and moxifloxacin placeboDrug

    Single dose moxifloxacin placebo and RO7033877 placebo

Study groups in NCT02165332
Study groupRoleWhat they receive
Part 1: PlaceboPlacebo comparatorSaline solution, given as a minimum of a 2 hour infusion
Receives: Drug: Part 1: SAD placebo
Part 1: RO7033877ExperimentalSingle ascending dose
Receives: Drug: Part 1: SAD RO7033877
Part 2: RO7033877ExperimentalSingle-dose 4-way crossover
Receives: Drug: Part 2: Treatment A, RO7033877; Drug: Part 2: Treatment B, RO7033877; Drug: Part 2: Treatment C, moxifloxacin; Drug: Part 2: Treatment D, RO7033877 and moxifloxacin placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Incidence of adverse events (AEs) after single, supratherapeutic dose of RO7033877

    Measured: Up to 30 days

  2. Part 1: Pharmacokinetic parameters derived from plasma and urine concentrations, single dose of RO7033877: Area under the curve (AUC)

    Measured: Day 1

  3. Part 2: Continuous, 12-lead Holter electrocardiogram (ECG) recordings

    Measured: Day -1 and 1 of each Period

Secondary outcomes (4)

  1. Incidence of AEs after single IV infusion of RO7033877

    Measured: Up to 9 weeks

  2. Part 2 only: Changes in other ECG parameters, descriptive analysis

    Measured: Up to 9 weeks

  3. Part 2 only: Changes in PK/PD relationships between any effect on ECG and RO7033877 plasma concentrations, descriptive analysis

    Measured: Up to 9 weeks

  4. Part 2: Area under the concentration-time curve (AUC) of RO7033877

    Measured: Day 1 of each Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionNov 2014
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02165332
Sponsor's protocol ID
NP29334
Status last verified
Nov 2016
First submitted
13 Jun 2014
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Part 1: SAD RO7033877, Part 2: Treatment A, RO7033877 and Part 2: Treatment B, RO7033877 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Incidence of adverse events (AEs) after single, supratherapeutic dose of RO7033877 (time frame: Up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02165332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

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