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Ascending Dose Study of CT1812 in Healthy Volunteers

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. Read our disclaimer for details. Identifier: NCT02570997
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
Cognition Therapeutics

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).

Condition or disease Intervention/treatment Phase
Cognitive Impairment Drug: CT1812 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : September 2015
Actual Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT02570997

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Australia, Victoria
Nucleus Network Limited
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Cognition Therapeutics
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Principal Investigator: Jason Lickliter, MD Nucleus Network Ltd
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Responsible Party: Cognition Therapeutics Identifier: NCT02570997    
Other Study ID Numbers: Cog 0101
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: October 2015
Keywords provided by Cognition Therapeutics:
Alzheimer's Disease
Mild Cognitive Impairment
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders