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Completed

NCT Number: NCT03774576

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BIOTRIAL

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7017773

Drug

Single doses of RO7017773

Itraconazole

Drug

Multiple doses of Itraconazole

Other names: Sporanox

Primary outcomes

  1. Maximum Concentration (Cmax) of RO7017773 in Plasma

    Time frame: Period 1 (RO7017773) and Period 2 (RO7017773 + Itraconazole)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2018
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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