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Drug Interaction Study of CT1812 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03716427
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Cognition Therapeutics

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: CT1812 Drug: tolbutamide Drug: dextromethorphan Drug: Omeprazole Drug: midazolam Phase 1

Detailed Description:

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).

Each subject will qualify for entry into the study within 35 days before admission to the clinical unit. Subjects will check into the clinical unit on Day -3 for baseline assessments. Each subject will receive a single dose of each of the probe drugs on Day -2 as a 'cocktail'. A single dose of CT1812 and each of the probe drugs will be co-administered on Day 6. On Days 1 through 5, subjects will receive a single daily dose of CT1812.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Sequential Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Fixed-Sequence Trial to Examine the Effect of Multiple-Dose CT1812 Administration on Standard Probes of CYP2C19 (Omeprazole), CYP2C9 (Tolbutamide), CYP2D6 (Dextromethorphan), and CYP3A4/5 (Midazolam) Activity in Healthy Adult Volunteers
Actual Study Start Date : November 10, 2016
Actual Primary Completion Date : December 27, 2016
Actual Study Completion Date : February 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Active Treatment- CT1812 560 mg
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)
Drug: CT1812
Drug: tolbutamide
Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of tolbutamide

Drug: dextromethorphan
Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of dextromethorphan

Drug: Omeprazole
Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of omeprazole

Drug: midazolam
Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of midazolam




Primary Outcome Measures :
  1. Area under the plasma-concentration time curve of CT1812 (Day 6) compared to the baseline values (Day -2) [ Time Frame: 10 days ]
    Single dose (Day -2 and Day 6) pharmacokinetic parameter Area under the plasma-concentration time curve



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent prior to initiation of any study-related procedures.
  2. Men and women ≥ 18 and ≤ 55 years of age
  3. In good health as determined by medical history, physical exam, laboratory examinations, ECG, and vital signs
  4. BMI between 18 and 35 kg/m2, inclusive
  5. Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction
  6. Non-smokers; defined as not having smoked in the previous 6 months
  7. Women who are neither pregnant (negative pregnancy test) nor nursing, and are either:

    1. Surgically sterile (bilateral tubal ligation, hysterectomy), or
    2. Postmenopausal with last natural menses greater than 12 months, or
    3. 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.

Exclusion Criteria:

  1. Known hypersensitivity or allergy to omeprazole, tolbutamide, dextromethorphan, midazolam, or CT1812
  2. Absence of one functional allele for CYP2D6, CYP2C9 or CYP2C19 at screening
  3. 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
  4. The presence of abnormal laboratory values which are considered clinically significant
  5. Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2)
  6. Received an investigational drug within a period of 30 days prior to enrollment in the study
  7. 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.
  8. Consumption of alcohol within 14 days prior to dose administration or during any in-patient period
  9. A positive urine drug screen including ethanol, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and opiates
  10. 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
  11. A history of difficulty with donating blood
  12. Donated whole blood within 45 days or blood products within 7 days prior to enrollment.

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 ClinicalTrials.gov identifier (NCT number): NCT03716427


Locations
United States, Michigan
Jasper Clinic
Kalamazoo, Michigan, United States, 49007
Sponsors and Collaborators
Cognition Therapeutics
Investigators
Study Director: Alyssa Galley Cognition Therapeutics, Inc.

Responsible Party: Cognition Therapeutics
ClinicalTrials.gov Identifier: NCT03716427     History of Changes
Other Study ID Numbers: COG0103
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Omeprazole
Midazolam
Dextromethorphan
Tolbutamide
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Hypoglycemic Agents