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A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03579719
Recruitment Status : Completed
First Posted : July 9, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will be a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. The study will be conducted at 1 site in the Netherlands.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Balovaptan Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Multiple Doses of Balovaptan in Healthy Volunteers
Actual Study Start Date : July 10, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Balovaptan + Itraconzole
Dosing in Period 1 will be separated by at least a 7 day washout period before dosing starts in Period 2. Participants will receive the study drugs in 2 periods over a total of 37 days.
Drug: Balovaptan

In Period 1, balovaptan will be administered orally once daily (qd) on Days 1 to 10.

In Period 2, balovaptan will be administered qd on Days 6 to 20.


Drug: Itraconazole
In Period 2, 200 mg itraconzole will be administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole will be administered qd.




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) for balovaptan [ Time Frame: Day 10 of Period 1 and Day 20 of Period 2 ]
  2. Maximum Plasma Concentration (Cmax) for M2 metabolites (as applicable) [ Time Frame: Day 10 of Period 1 and Day 20 of Period 2 ]
  3. Maximum Plasma Concentration (Cmax) for M3 metabolites [ Time Frame: Day 10 of Period 1 and Day 20 of Period 2 ]
  4. Area under the concentration vs time curve over the dosing interval for balovaptan [ Time Frame: Day 10 of Period 1 and Day 20 of Period 2 ]
  5. Area under the concentration vs time curve over the dosing interval for M2 metabolites (as applicable) [ Time Frame: Day 10 of Period 1 and Day 20 of Period 2 ]
  6. Area under the concentration vs time curve over the dosing interval for M3 metabolites [ Time Frame: Day 10 of Period 1 and Day 20 of Period 2 ]

Secondary Outcome Measures :
  1. Time to Maximum Observed Plasma Concentration for balovaptan [ Time Frame: Day 10 of Period 1; Day 15 and Day 20 of Period 2 ]
  2. Time to Maximum Observed Plasma Concentration for M2 metabolites (as applicable) [ Time Frame: Day 10 of Period 1; Day 15 and Day 20 of Period 2 ]
  3. Time to Maximum Observed Plasma Concentration for M3 metabolites [ Time Frame: Day 10 of Period 1; Day 15 and Day 20 of Period 2 ]
  4. Trough Plasma Concentration for balovaptan [ Time Frame: Day 1, 3, 5, 8, 9, 10 in Period 1; Day 6, 8, 10, 13, 14, 16, 18, 19, 20 in Period 2 ]
  5. Trough Plasma Concentration for M2 (as applicable) [ Time Frame: Day 1, 3, 5, 8, 9, 10 in Period 1; Day 6, 8, 10, 13, 14, 16, 18, 19, 20 in Period 2 ]
  6. Trough Plasma Concentration for M3 [ Time Frame: Day 1, 3, 5, 8, 9, 10 in Period 1; Day 6, 8, 10, 13, 14, 16, 18, 19, 20 in Period 2 ]
  7. Time to Steady State for Balovaptan [ Time Frame: Day 10 in Period 1 and Day 20 in Period 2 ]
  8. Percentage of participants with adverse events [ Time Frame: Up to 21 days postdose ]


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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. 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 2 acceptable contraceptive methods during the treatment period and for 90 days after the last dose of study drug.
  • For men: agreement to use contraceptive measures, and agreement to refrain from donating sperm until 90 days after the last dose of study drug.

Exclusion Criteria:

  • Female subjects who are pregnant or lactating.
  • 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.

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): NCT03579719


Locations
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Netherlands
Pra International Group B.V
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03579719     History of Changes
Other Study ID Numbers: WP40609
2018-001454-10 ( EudraCT Number )
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors