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OpenTrials
Completed

NCT Number: NCT03507569

Open Label, Adaptive, Parallel Group PET Study Using RO7017773 And [11C] RO15-4513

This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.

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Key information

Age range

23 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hammersmith Medicines Research; Central Middlesex Hospital

London, NW10 7EW, United Kingdom

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 chemisty, serology, and urinalysis), as judged by the Investigator.
  • Males 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 CNS infections
  • Clinically significant abnormal finding from the MRI performed after the initial screening examination
  • Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
  • Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm
  • History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment

Treatment and study plan

RO7017773

Drug

RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.

[11C] Ro15-4513

Other

At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.

Primary outcomes

  1. Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773

    Time frame: Baseline up to 48 hours (hrs)

  2. Plasma Concentrations of RO7017773

    Time frame: Baseline up to 48 hrs

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: From treatment initiation until 14 days after the last dose of study treatment.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Non-Randomized Open Label, Adaptive, Parallel Group, Human Positron Emission Tomography (PET) Study to Assess Occupancy of Brain alpha5-Containing GABAA Receptors of Ro7017773 Using [11C] Ro15-4513 Following Single Oral Doses in Healthy Participants

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 25, 2018
Registry last updated
Sep 30, 2019

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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