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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03774576
Recruitment Status : Completed
First Posted : December 13, 2018
Results First Posted : May 7, 2020
Last Update Posted : May 7, 2020
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 : 14 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 : March 14, 2019
Actual Study Completion Date : March 14, 2019

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 multiple doses of itraconazole
Drug: RO7017773
Single doses of RO7017773

Drug: Itraconazole
Multiple doses of Itraconazole
Other Name: Sporanox

Primary Outcome Measures :
  1. Maximum Concentration (Cmax) of RO7017773 in Plasma [ Time Frame: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole) ]

Secondary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) [ Time Frame: 12 weeks ]
  2. Change in Suicide Risk as Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: From screening visit through Period 2 Day 11 ]
    The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior. Categories have binary responses (yes/no) and include: Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation or behavior is indicated by a "yes" answer to any of the listed categories. A score of 0 is assigned if no suicide risk is present.

  3. Cmax of Itraconazole in Plasma [ Time Frame: Period 2 ]

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.

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

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 identifier (NCT number): NCT03774576

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Rennes, France, 35042
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Hoffmann-La Roche:
Study Protocol  [PDF] November 14, 2018
Statistical Analysis Plan  [PDF] April 23, 2019

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Responsible Party: Hoffmann-La Roche Identifier: NCT03774576    
Other Study ID Numbers: BP40822
2018-002889-40 ( EudraCT Number )
First Posted: December 13, 2018    Key Record Dates
Results First Posted: May 7, 2020
Last Update Posted: May 7, 2020
Last Verified: April 2020

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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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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