Drug Interaction Study of CT1812 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This is Phase 1, single-center, open-label, single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs (tolbutamide, midazolam, dextromethorphan and omeprazole).

Key facts

Study ID

NCT03716427

Run by

Cognition Therapeutics

People needed

16

Starts

2016-11-10

Expected to finish

2017-02-15

Last updated by the study team

2018-10-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Willing and able to provide written informed consent prior to initiation of any study-related procedures.
• Men and women ≥ 18 and ≤ 55 years of age
• In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs
• BMI between 18 and 35 kg/m2, inclusive
• Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction
• Non-smokers; defined as not having smoked in the previous 6 months
• Women who are neither pregnant (negative pregnancy test) nor nursing, and are either:
• Surgically sterile (bilateral tubal ligation, hysterectomy), or
• Postmenopausal with last natural menses greater than 12 months, or
• Premenopausal and using an acceptable barrier form of birth control from screening until two-weeks post discharge. Acceptable forms of birth control include abstinence and any double combination of: hormonal contraceptive, intrauterine device (IUD), male or female condom, diaphragm, sponge, and cervical cap. Spermicides may be used, but is not considered one of the required double barrier methods. All premenopausal female subjects (regardless of whether they are surgically sterile) must have a negative serum pregnancy test at screening and baseline.

You may not qualify if…

• Known hypersensitivity or allergy to omeprazole, tolbutamide, dextromethorphan, midazolam, or CT1812
• Absence of one functional allele for CYP2D6, CYP2C9 or CYP2C19 at screening
• Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
• The presence of abnormal laboratory values which are considered clinically significant
• Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2)
• Received an investigational drug within a period of 30 days prior to enrollment in the study
• Received any drug therapy within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion is extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism.
• Consumption of alcohol within 14 days prior to dose administration or during any in-patient period
• A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates
• Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid within the past two years, or any history of drug abuse or addiction within the past two years
• A history of difficulty with donating blood
• Donated whole blood within 45 days or blood products within 7 days prior to enrollment.

Where it is running

• Jasper Clinic — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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