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A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03774576
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
The purpose of this study is to investigate the effect of multiple oral doses of itraconazole on the pharmacokinetics of RO7017773 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: RO7017773 Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-Randomized, Open Label, One Sequence, Two-Period Cross-Over Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : December 28, 2018
Actual Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RO7017773
Single dose of RO7017773
Drug: RO7017773
Single doses of RO7017773

Experimental: RO7017773 and Itraconazole
Single dose of RO7017773 and multiples doses of itraconazole
Drug: RO7017773
Single doses of RO7017773

Drug: Itraconazole
Multiple doses of Itraconazole
Other Name: Sporanox




Primary Outcome Measures :
  1. Plasma Concentrations of RO7017773 [ Time Frame: At pre-defined intervals up to 12 days post dose of study drug ]

Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline through the end of study (up to approximately 10 weeks) ]
  2. Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Between start and pre-defined intervals up to 11 days post dose of study drug ]
  3. Plasma Concentrations of Itraconazole [ Time Frame: At pre-defined intervals up to 7 days after the last dose of study drug ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy (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, serology and urinalysis) as judged by the Investigator.
  • Male and women of non-childbearing potential (WONCBP)

Exclusion Criteria

  • History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or central nervous system (CNS) infections (e.g., meningitis)
  • History of clinically significant hypersensitivity or allergic reactions
  • Abnormal blood pressure
  • Abnormal pulse rate
  • History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
  • Positive test for drugs of abuse or alcohol
  • Evidence of human immunodeficiency virus (HIV) infection
  • Presence of hepatitis B surface antigen (HBsAg) or positive HCV antibody test result at screening or within 3 months prior to starting study treatment
  • Participants who regularly smoke more than 5 cigarettes daily or the equivalent and are unable or unwilling not to smoke during the in-house period

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): NCT03774576


Locations
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France
BIOTRIAL
Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03774576     History of Changes
Other Study ID Numbers: BP40822
2018-002889-40 ( EudraCT Number )
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: January 21, 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