First in Human Study of CT-1500 in Healthy Participants

Circadian Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CT-1500; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05070702

CT-1500-01

Details and patient eligibility

About

This study is a single center, randomized, placebo-controlled, double-blind study of CT-1500 in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses of orally administered CT-1500 compared to placebo.

Full description

This study is a single center, randomized, placebo-controlled, double-blind study of CT-1500 in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of single ascending doses and multiple ascending doses of orally administered CT-1500 compared to placebo. It is planned for 5 dose levels to be investigated in the single ascending dose (SAD) part (Part 1) of the study, between 5 mg to 120 mg. Three dose levels are proposed for investigation in the multiple ascending dose (MAD) part (Part 2) of the study.

Enrollment: 64 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy with the exception of those medical conditions allowed per the study criteria
• Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures
• Body Mass Index (BMI) of 18.5 to 32 kg/m2 and weight >48 kg
• Systolic Blood Pressure (BP) of 90-140 mmHg, Diastolic BP of 40-90 mmHg and Heart Rate between 40 and 100 bpm
• Forced Expiratory Volume in one second (FEV1) > 85% predicted
• Clinical laboratory results at screening and Day -1 to be within normal limits unless deemed as not clinically significant by the investigator
• Willing to consume bovine containing products (investigational product capsules are bovine gelatin in origin);
• Agree not to donate blood or plasma products for at least 30 days after the end of study (EOS) visit
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1, must not be breastfeeding, lactating or planning a pregnancy and must use an acceptable form of contraception during the treatment period and for 32 days after the last dose
• Male participants with a female partner of childbearing potential must agree to use an acceptable form of contraception during the treatment period and for 92 days after the last dose

Exclusion criteria

• Significant current or historical disease, including intercurrent illness in the 4 weeks prior to screening
• Current or historical diagnosis of sleep disorders
• Hepatic disorders other than benign unconjugated hyperbilirubinaemia
• History of moderate or severe psychiatric illness
• History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure
• Heavy caffeine drinker in the last 3 months. If subjects are willing to reduce their caffeine intake for 14 days prior to first dose and for the duration of the study, they can participate
• Hypersensitivity to CT-1500 or any of the inert excipients in the capsule formulation
• Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV) or positive human immunodeficiency virus (HIV) test
• Treatment with an investigational drug within 30 days or less than 5 half-lives (whichever is longer) prior to screening
• Use of prescription medication within 14 days prior to investigational product administration until the end of study visit, with the exception of oral contraceptives.
• Use of over-the-counter medication and supplements for 7 days prior to investigation product administration until the end of study visit. Exceptions at the discretion of the investigator.
• Receipt of a Coronavirus disease 2019 (COVID-19) vaccine within 14 days prior to investigational product administration or a planned second dose of a COVID-19 vaccine during study participation
• Use of tobacco or nicotine-containing products in excess of 2 cigarettes per day within 1 month prior to screening
• Major surgery in the 6 months preceeding screening or planned surgery during the study
• Donated blood or blood products or had a substantial loss of blood with 3 months prior to screening
• A history of drug abuse or addiction
• A history of alcoholism or consumption of more than 3 alcoholic drinks per day or consumption of alcohol within 48 hours prior to first dose
• Unable to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration until completion of the confinement period;
• Unable to avoid heavy exercise (eg, marathon runners, weight-lifters) from 48 hours prior to investigational product administration until completion of the confinement period

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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64 participants in 4 patient groups, including a placebo group

CT-1500 Active (SAD)

Experimental group

Description:

6 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of CT-1500 between 5 mg and 120 mg

Treatment:

Drug: CT-1500

Placebo (SAD)

Placebo Comparator group

Description:

2 out of 8 participants per cohort (up to 5 cohorts) will be randomized to receive a single oral dose of matching placebo

Treatment:

Drug: Placebo

CT-1500 Active (MAD)

Experimental group

Description:

6 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of CT-1500 between 5 and 45 mg

Treatment:

Drug: CT-1500

Placebo (MAD)

Placebo Comparator group

Description:

2 out of 8 participants per cohort (up to 3 cohorts) will be randomized to receive 7 daily oral doses of matching placebo

Treatment:

Drug: Placebo