Study of effects of AUT00206 in healthy males - ketamine challenge

Phase 1

Conditions: Schizophrenia
MedDRA version: 19.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2016-000216-14-GB

Lead Sponsor: Autifony Therapeutics Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

Male aged 18 to 45 years, inclusive at Visit 1
Healthy on the basis of medical history, psychiatric history, physical examination, vital signs, 12-lead electrocardiogram (ECG), haematology, blood chemistry and urinalysis within 6 weeks of Visit 2
Right-handed
Not a regular smoker (maximum 5 cigarettes per week or equivalent)
Competent English speakers
Acceptable weight as defined by Body Mass Index (BMI) (weight [kg]/height [m]²) range of 18 to 30 kg/m², inclusive at Visit Participants with partner(s) of childbearing potential must take appropriate precautions to avoid fathering a child from Visit 1 until 4 months after the last dose of study drug and use barrier contraception, in addition to their partner(s) using another method. Acceptable forms of contraception are as follows:
Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or suppository;
Non-hormone containing intrauterine methods: intrauterine devices or systems.
Provision of written informed consent before initiation of any study related procedures.
Be able to understand and comply with the requirements of the study, as judged by the Investigator.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

History of positive test for hepatitis B, hepatitis C, human immunodeficiency virus (HIV)-1 or HIV-2.
Sitting (5 minutes) blood pressure outside the ranges of 90 to 150 mmHg systolic, inclusive, and 60 to 90 mmHg diastolic, inclusive, unless judged not clinically significant by the responsible physician.
Corrected QT interval (QTcF) > 450 msec (based on the Fridericia correction where QTcF = QT/RR0.33).
Known contraindication to the use of ketamine
Participants in whom an elevation of blood pressure would constitute a serious hazard
Hypersensitivity to the drug or its components
Participants with severe coronary or myocardial disease, cerebrovascular accident or cerebral trauma
History of, or presents (in the opinion of the responsible physician) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, depression, epilepsy, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation).
History of, or current condition of, migraine headaches or has undergone operations to the head.
History of significant claustrophobia.
Recreational drug use within 3 months prior to Visit 1.
Intake of more than 21 units of alcohol weekly.
Positive alcohol breath test at Visit 1 or Visit 2.
Positive urine drug screen at Visit 1 or Visit 2.
Consumption of large amounts of caffeinated drinks (more than 8 cups of standard caffeinated drinks [tea, instant coffee] or 6 cups of stronger coffee or other drinks containing methylxanthines such as Coca Cola or Red Bull per day).
Consumption of any food or any drinks containing cranberry, pomegranate, star fruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges within 3 days prior to Visit 2.
Use of a prescription medicine in the 28 days before Visit 2, unless the responsible physician considers that it would not interfere with the study (e.g. acetaminophen).
Use of an over-the-counter medicine, with the exception of acetaminophen (paracetamol), in the 7 days before Visit 2, unless the responsible physician considers that it would not interfere with the study.
Has participated in another study and/or taken experimental drugs and/or used experimental medical devices within 30 days of Visit 1 or within a period less than 5 times the drug’s half-life, whichever is longer
Previous randomisation in the present study.
Fulfils any of the MRI contraindications on the standard site radiography screening questionnaire (e.g. history of surgery involving metal implants).