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Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03808298
Recruitment Status : Completed
First Posted : January 17, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the QTc interval in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Balovaptan therapeutic dose Treatment A Drug: Balovaptan supra-therapeutic dose Treatment B Drug: Active control [moxifloxacin] on Day 2 Treatment C Drug: Active control [moxifloxacin] on Day 15 Treatment D Drug: Placebo for Balovaptan Treatment C Drug: Placebo for Balovaptan Treatment D Drug: Placebo for Moxifloxacin Treatment A Drug: Placebo for moxifloxacin Treatment B Drug: Moxifloxacin Treatment C Drug: Placebo for moxifloxacin Treatment C Drug: Placebo for moxifloxacin Treatment D Drug: Moxifloxacin Treatment D Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects
Actual Study Start Date : February 7, 2019
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : July 5, 2019

Arm Intervention/treatment
Experimental: Treatment Sequnces 1: A, B, C Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 2 Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule

Drug: Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Experimental: Treatment Sequence 2: A, C, B Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Experimental: Treatment Sequence 3: B, A, C Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 2 Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule

Drug: Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Experimental: Treatment Sequence 4: B, C, A Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 2 Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule

Drug: Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Experimental: Treatment Sequence 5: C, A, B Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 2 Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule

Drug: Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Experimental: Treatment Sequence 6: C, B, A Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 2 Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule

Drug: Placebo for Balovaptan Treatment C
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Moxifloxacin Treatment C
Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for moxifloxacin Treatment C
Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Experimental: Treatment Sequence 7: A, B, D Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Placebo for moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Experimental: Treatment Sequence 8: A, D, B Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Placebo for moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Experimental: Treatment Sequence 9: B, A, D Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Placebo for moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Experimental: Treatment Sequence 10: B, D, A Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Placebo for moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Experimental: Treatment Sequence 11: D, A, B Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Placebo for moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Experimental: Treatment Sequence 12: D, B, A Drug: Balovaptan therapeutic dose Treatment A
Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days.

Drug: Balovaptan supra-therapeutic dose Treatment B
Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Drug: Active control [moxifloxacin] on Day 15 Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Drug: Placebo for Balovaptan Treatment D
Days 1-14: Matching placebo for balovaptan for 14 days.

Drug: Placebo for Moxifloxacin Treatment A
Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Placebo for moxifloxacin Treatment B
Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Drug: Placebo for moxifloxacin Treatment D
Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Drug: Moxifloxacin Treatment D
Day 15: A single oral dose of 400 mg moxifloxacin capsule.




Primary Outcome Measures :
  1. Placebo-Corrected, Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings [ Time Frame: Baseline (Predose Day 1), Day 14. (Each treatment period is 15 days.) ]

Secondary Outcome Measures :
  1. Placebo-Corrected, Change-From-Baseline QTcF at Dose Level B Measured on 12-Lead ECGs Extracted From Continuous Recordings [ Time Frame: Baseline (Predose Day 1), Day 1. (Each treatment period is 15 days.) ]
  2. Placebo-Corrected, Change-From-Baseline QTcF at Dose Level A Measurred on 12-Lead ECGs Extracted From Continuous Recordings [ Time Frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) ]
  3. Placebo-Corrected, Change-From-Baseline Heart Rate Measured on 12-Lead ECGs Extracted From Continuous Recordings [ Time Frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) ]
  4. Placebo-Corrected, Change-From-Baseline PR Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings [ Time Frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) ]
  5. Placebo-Corrected, Change-From-Baseline QRS Interval Measured on 12-Lead ECGs Extracted From Continuous Recordings [ Time Frame: Baseline (Predose Day 1), Day 1 and Day 14. (Each treatment period is 15 days.) ]
  6. Number of Categorical Outliers for QTcF [ Time Frame: Day 1 and Day 14 (Each treatment period is 15 days.) ]
  7. Number of Categorical Outliers for HR [ Time Frame: Day 1 and Day 14 (Each treatment period is 15 days.) ]
  8. Number of Categorical Outliers for PR [ Time Frame: Day 1 and Day 14 (Each treatment period is 15 days.) ]
  9. Number of Categorical Outliers for QRS [ Time Frame: Day 1 and Day 14 (Each treatment period is 15 days.) ]
  10. Number of Treatment Emergent Changes of T-Wave Morphology [ Time Frame: Day 1 and Day 14 (Each treatment period is 15 days.) ]
  11. Number of Treatment Emergent Changes of U-Wave Presence [ Time Frame: Day 1 and Day 14 (Each treatment period is 15 days.) ]
  12. Tmax of Balovaptan [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  13. Tmax of M2 Metabolite [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  14. Tmax M3 Metabolite [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  15. Cmax of Balovaptan [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  16. Cmax of M2 Metabolite [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  17. Cmax of M3 Metabolite [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  18. AUC0-24 of Balovaptan [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  19. AUC0-24 of M2 Metabolite [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  20. AUC0-24 of M3 Metabolite [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 and Day 14. (Each treatment period is 15 days.) ]
  21. Tmax of Moxifloxacin [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.) ]
  22. Cmax of Moxifloxacin [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.) ]
  23. AUC0-24 of Moxifloxacin [ Time Frame: Predose, and 0.5, 1.0, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.) ]
  24. Pharmacokinetic-Pharmacodynamic Model of Balovaptan Concentrations Versus QTcF Changes [ Time Frame: Baseline, Day 1 and Day 14. (Each treatment period is 15 days.) ]
    The relationship between plasma concentrations of balovaptan and ΔΔQTcF will be evaluated using a linear mixed-effects modeling approach.

  25. Pharmacokinetic-Pharmacodynamic Model of M2 Metabolite Concentrations Versus QTcF Changes [ Time Frame: Baseline, Day 1 and Day 14. (Each treatment period is 15 days.) ]
    The relationship between plasma concentrations of M2 (as appropriate) and ΔΔQTcF will be evaluated using a linear mixed-effects modeling approach.

  26. Pharmacokinetic-Pharmacodynamic Model of M3 Metabolite Concentrations Versus QTcF Changes [ Time Frame: Baseline, Day 1 and Day 14. (Each treatment period is 15 days.) ]
    The relationship between plasma concentrations of M3 and ΔΔQTcF will be evaluated using a linear mixed-effects modeling approach.

  27. Pharmacokinetic-Pharmacodynamic Model of Moxifloxacin Concentrations Versus QTcF Changes [ Time Frame: Baseline, Days 2 (Treatment C) or 15 (Treatment D). (Each treatment period is 15 days.) ]

    The relationship between plasma concentrations of Moxifloxacin [as appropriate] and ΔΔQTcF will be evaluated using a linear mixed-effects modeling approach.

    Moxifloxacin PK samples: will only be analyzed if the moxifloxacin assay sensitivity test fails; in such case, moxifloxacin plasma levels matched to the QT data by timepoint across subjects will be used for exposure response analysis of the QT effect.


  28. QTcF Changes [ Time Frame: Baseline, Day 1 and Day 14. (Each treatment period is 15 days.) ]
    ΔΔQTcF will be evaluated using a linear mixed-effects modeling approach.

  29. Placebo-Corrected, Change-From-Baseline QTcF Measured on 12 Lead ECGs Extracted From Continuous Records [ Time Frame: Baseline, Day 2 and Day 15. (Each treatment period is 15 days.) ]
  30. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 20 weeks. ]


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 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, urinalysis, and serology.
  • Body Mass Index of 18 to 30 kg/m2, inclusive.
  • For women of childbearing potential: agreement to use at least 1 acceptable form of contraception during the entire study and for 90 days following last dose of study drug.
  • For men: vasectomized, agreement to remain abstinent or use of a condom during intercourse. Must also agree to refrain from donating sperm.
  • Fluent in English.

Exclusion Criteria:

  • If female, a positive pregnancy test at screening or prior to Day 1 of any Treatment Period.
  • Lactating women.
  • Any condition or disease detected during the medical interview / physical examination that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the Investigator or designee.

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): NCT03808298


Locations
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United States, Kansas
PRA International Clinical Pharmacology Center (EDS US Clinic)
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03808298     History of Changes
Other Study ID Numbers: WP40734
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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