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Ascending Dose Study of CT1812 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cognition Therapeutics
ClinicalTrials.gov Identifier:
NCT02570997
First received: September 28, 2015
Last updated: September 5, 2016
Last verified: October 2015
  Purpose
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).

Condition Intervention Phase
Cognitive Impairment Drug: CT1812 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Cognition Therapeutics:

Primary Outcome Measures:
  • Incidence and review of Treatment Emergent Adverse Events [Safety and Tolerability] [ Time Frame: up to 35 days ]

    Treatment Emergent Adverse Events will be assessed by reviewing:

    • physical examinations,
    • monitoring vital signs,
    • monitoring clinical and laboratory assessments,
    • monitoring ECGs.


Enrollment: 80
Study Start Date: September 2015
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: CT1812
Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.
Other Name: Study drug
Placebo Comparator: Matching Placebo
In cohorts 1-6, 8 subjects will be enrolled. 6 subjects will receive matching placebo.
Drug: Placebo
Matching placebo administered.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02570997

Locations
Australia, Victoria
Nucleus Network Limited
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Cognition Therapeutics
Investigators
Principal Investigator: Jason Lickliter, MD Nucleus Network Ltd
  More Information

Responsible Party: Cognition Therapeutics
ClinicalTrials.gov Identifier: NCT02570997     History of Changes
Other Study ID Numbers: Cog 0101
Study First Received: September 28, 2015
Last Updated: September 5, 2016

Keywords provided by Cognition Therapeutics:
Alzheimer's Disease
Mild Cognitive Impairment

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2017