Drug Interaction Study of CT1812 in Healthy Volunteers

NCT03716427 | Completed Phase 1 FDA Drug

• 1 other identifier: COG0103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Area under the plasma-concentration time curve of CT1812 (Day 6) compared to the baseline values (Day -2)

  Single dose (Day -2 and Day 6) pharmacokinetic parameter Area under the plasma-concentration time curve

  10 days

Study Arms (1)

Active Treatment- CT1812 560 mg

EXPERIMENTAL

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; Drug: dextromethorphan; Drug: Omeprazole; Drug: midazolam

Interventions

CT1812 DRUG

Active Treatment- CT1812 560 mg

tolbutamide DRUG

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

Active Treatment- CT1812 560 mg

dextromethorphan DRUG

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

Active Treatment- CT1812 560 mg

Omeprazole DRUG

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

Active Treatment- CT1812 560 mg

midazolam DRUG

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

Active Treatment- CT1812 560 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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
• 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.

Sponsors & Collaborators

• Cognition Therapeutics: lead

Study Sites (1)

Jasper Clinic

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Interventions

Tolbutamide; Dextromethorphan; Omeprazole; Midazolam

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Benzodiazepines; Benzazepines

Study Officials

• Alyssa Galley

  Cognition Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: October 23, 2018
• Study Start: November 10, 2016
• Primary Completion: December 27, 2016
• Study Completion: February 15, 2017
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)