A Study in Healthy Volunteers to Assess the Effect of Fedovapagon on the QT/QTC Interval

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vantia Ltd
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Provide signed and dated informed consent before any study-specific procedures are conducted.

• Healthy males and females 18 to 55 years of age (inclusive).

• No clinically significant abnormal physical findings.

• No clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission.

• Have a body mass index (BMI) ≥18.0 to ≤29.9 kg/m2 (weight: ≥50 kg and ≤100 kg) at the Screening visit.

• Be judged by the Investigator to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at the Screening visit and before the first administration of fedovapagon, moxifloxacin or placebo.

• Have no clinically significant abnormality on an ECG performed at the Screening visit and on admission to the study center.

• Have a normal resting blood pressure.

• Must be able to understand and be willing to comply with study procedures, restrictions and requirements.

• Agree to refrain from the consumption of grapefruit or grapefruit juice beginning 1 week prior to administration of the initial administration fedovapagon, moxifloxacin or placebo, throughout the trial.

• Agree to refrain from the consumption of alcohol and/or methylxanthines e.g., caffeine (coffee, tea and cola) beginning 96 hours prior to administration of the initial administration of fedovapagon, moxifloxacin or placebo, throughout the trial.

• Current non-smokers who have not used any nicotine-containing products (chewed or smoked) or replacement products including electronic cigarettes in the 45 days prior to screening.

• Woman of child-bearing potential must be using effective methods (failure rate <1%) of birth control at least 4 weeks prior to Screening until 4 weeks after the administration of fedovapagon, moxifloxacin or placebo.

• Male subjects should be willing to use a condom with spermicide during sexual activity with female partners of child-bearing potential and must not donate sperm. Female sexual partners of male subjects should be willing to avoid pregnancy.