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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02570997




Registration number
NCT02570997
Ethics application status
Date submitted
28/09/2015
Date registered
8/10/2015
Date last updated
7/09/2016

Titles & IDs
Public title
Ascending Dose Study of CT1812 in Healthy Volunteers
Scientific title
A Two-Part, Double-Blind, Placebo-Controlled, Phase I Study of the Safety Pharmacokinetics of Single and Multiple Ascending Doses of CT1812 in Healthy Volunteers
Secondary ID [1] 0 0
Cog 0101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Impairment 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CT1812
Treatment: Drugs - Placebo

Active comparator: CT1812 - In cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive CT1812. Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.

Should an MTD not be identified, additional cohorts at higher doses may be enrolled. The maximum dose administered will not exceed 1350mg.

Placebo comparator: Matching Placebo - In cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive matching placebo.


Treatment: Drugs: CT1812
Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.

Treatment: Drugs: Placebo
Matching placebo administered.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and review of Treatment Emergent Adverse Events [Safety and Tolerability]
Timepoint [1] 0 0
up to 35 days

Eligibility
Key inclusion criteria
* Willing and able to provide written informed consent prior to initiation of any study-related procedures.
* Men and women either = 18 and = 55 years of age or = 65 and =75 years of age, depending on cohort.
* In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs.
* BMI between 19 and 34 kg/m2, inclusive.
* Weight between 50 and 100 kg, inclusive.
* ECG without clinically significant pathologic abnormalities and with QTcB <450.
* Normotensive as defined by systolic BP = 150 mmHg and diastolic BP = 90 mmHg.
* Non-smokers.
* No suicidal ideation, as demonstrated by a score of "0" on the Columbia Suicide Severity Rating Scale (C-SSRS). Part B Only.
* Women who are neither pregnant (negative pregnancy test) nor nursing, and are either surgically sterile or postmenopausal.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any chronic medical condition (such as type 1 diabetes) requiring chronic treatment that might increase the risk to the subject or confound interpretation of safety observations.
* Evidence of active infection requiring antibiotic therapy within 14 days prior to screening.
* Medical history of vasculitis or any autoimmune disease excluding seasonal allergic rhinitis and childhood history of atopic dermatitis.
* History of any treatment for cancer within the past 2 years, other than basal cell or squamous cell carcinoma of the skin.
* Seropositive for human immunodeficiency virus (HIV).
* History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for Hepatitis B surface antigen [HbsAg] or anti-Hepatitis C [HCV] antibody).
* Clinically significant abnormalities in specified screening laboratory tests
* All prescription, over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of calcium/vitamin D supplements, nasal steroids, ocular medications, and paracetamol at the discretion of the Investigator).
* Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing in this study.
* Any disorder that could interfere with the absorption, distribution, metabolism or excretion of drugs.
* Psychiatric history of current or past psychosis, bi-polar disorder, clinical depression, or anxiety disorder requiring chronic medication within the past 5 years.
* History of substance abuse.
* History of substance or drug dependence or positive urine drug screen at screening visit.
* History of head injury.
* Chronic kidney disease.
* Signs of dementia or cognitive impairment in the elder cohorts.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cognition Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted in two phases: a single ascending dose (SAD) phase "Part A", followed by a multiple ascending dose (MAD) phase "Part B". In Part A, subjects will receive one dose of study drug. In Part B, subjects within a cohort will receive the same dose daily for 14 days. In both parts, sequential cohorts will be exposed to increasing doses of CT1812 in order to identify the maximum tolerated dose (MTD).
Trial website
https://clinicaltrials.gov/study/NCT02570997
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MD
Address 0 0
Nucleus Network Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02570997