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Safety, Blood Levels and Effects of AUT00201

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158453
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Autifony Therapeutics Limited

Brief Summary:

The study medicine is a potential future treatment for schizophrenia, an illness that affects the way that people think, feel or behave. It is not clear what causes schizophrenia, but it's been linked to chemical imbalance in the brain. It is hoped that the study medicine will activate specific sites in the brain to help correct that imbalance. Current treatments for schizophrenia don't work very well and can cause unpleasant side effects. It is hoped that the study medicine will work better, and have fewer side effects than existing medicines.

In this 2 part study (Part A: up to 40 healthy male subjects and up to 8 healthy female subjects, Part B: up to 32 healthy male subjects) the primary aim is to assess how safe the study medicine is in healthy men and women.

This study will be in 2 parts, as follows:

Part A will assess single doses of AUT00201 and Part B will assess multiple doses. Part A will be divided into 3 sub-parts: Part A1 will assess single ascending doses in healthy men, Part A2 will assess single ascending doses in healthy women, and Part A3 will assess the effect of food on the PK of AUT00201 in healthy men.

A pharmaceutical company, Autifony Therapeutics Limited, is funding the study. The study will take place at 1 centre in London.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AUT00201 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Single and Repeated Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AUT00201 in Healthy Male and Female Volunteers
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Active Comparator: AUT00201 Drug: AUT00201
Oral dose of AUT00201

Placebo Comparator: Placebo Drug: Placebo
Oral dose of placebo




Primary Outcome Measures :
  1. Percent of subjects with treatment-related adverse events [ Time Frame: Study Duration (2 weeks post last dose) ]


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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normotensive male (all groups except Part A2) or female (Part A2 only) volunteers
  • Must have body mass index (BMI) of 18.0-31.0 kg/m2
  • Must be healthy based on clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
  • Must be able to give fully informed written consent.

Exclusion Criteria:

History or presence of

  • Epilepsy
  • Severe head injury, or any other chronic neurological condition or any psychiatric disorder
  • Abnormal screening EEG (Part A1 and Part B only)
  • Positive tests for hepatitis B & C, HIV
  • Severe adverse reaction to any drug
  • Sensitivity to trial medication
  • Drug or alcohol abuse
  • Use of over-the-counter medication within previous 7 days (with the exception of Paracetamol [acetaminophen])
  • Prescribed medication during previous 28 days
  • Participation in other clinical trials of unlicensed medicines
  • Loss of more than 400 mL blood, within the previous 3 months
  • Vital signs or QTcF interval outside the acceptable range
  • Clinically relevant abnormal findings at the screening assessment
  • Acute or chronic illness
  • Clinically relevant abnormal medical history or concurrent medical condition
  • Positive result for suicidal ideation or behaviour using the Colombia suicide severity rating scale (C-SSRS)
  • Possibility that volunteer will not cooperate
  • Pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception

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): NCT04158453


Contacts
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Contact: HMR Recruitment Team 08007838792 recruit@hmrlondon.com

Locations
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United Kingdom
Hammersmith Medicines Research Recruiting
London, United Kingdom, NW10 7EW
Contact: HMR Recruitment Team         
Sponsors and Collaborators
Autifony Therapeutics Limited
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Responsible Party: Autifony Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04158453    
Other Study ID Numbers: AUT011201
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Autifony Therapeutics Limited:
Healthy Volunteer
Schizophrenia