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.|
|ClinicalTrials.gov Identifier: NCT02570997|
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : September 7, 2016
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment||Drug: CT1812 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|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|
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.
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.
Matching placebo administered.
- 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.
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.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
- 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.
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): NCT02570997
|Nucleus Network Limited|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Jason Lickliter, MD||Nucleus Network Ltd|
|Responsible Party:||Cognition Therapeutics|
|Other Study ID Numbers:||
|First Posted:||October 8, 2015 Key Record Dates|
|Last Update Posted:||September 7, 2016|
|Last Verified:||October 2015|
Mild Cognitive Impairment