Healthy Clinical Trial
Official title:
First in Human Study in Healthy Subjects to Investigate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Repeat Doses of CT-1500
Verified date | July 2022 |
Source | Circadian Therapeutics Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | July 7, 2022 |
Est. primary completion date | July 7, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Nucleus Network | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Circadian Therapeutics Ltd | Neuroscience Trials Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events (AEs) and Serious Adverse Events (SAEs) during the SAD part of the study | Incidence and severity of AEs and SAEs | Initiation of dosing through 7 days post dose | |
Primary | Adverse Events and Serious Adverse Events during the MAD part of the study | Incidence and severity of AEs and SAEs | Initiation of dosing through 14 days post dose | |
Primary | Tolerability of CT-1500 as defined by change from baseline in Heart Rate (SAD) | Initiation of dosing through 7 days post dose | ||
Primary | Tolerability of CT-1500 as defined by change from baseline in Heart Rate (MAD) | Initiation of dosing through 14 days post dose | ||
Primary | Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (SAD) | Initiation of dosing through 7 days post dose | ||
Primary | Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (MAD) | Initiation of dosing through 14 days post dose | ||
Primary | Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram Assessment (SAD) | Change in QT interval from baseline | Initiation of dosing through 7 days post dose | |
Primary | Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram assessment (MAD) | Change in QT interval from baseline | Initiation of dosing through 14 days post dose | |
Primary | Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (SAD) | Change from baseline in Forced Expiratory Volume in 1 second (FEV1) | Initiation of dosing through 7 days post dose | |
Primary | Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (MAD) | Change from baseline in Forced Expiratory Volume in 1 second (FEV1) | Initiation of dosing through 14 days post dose | |
Primary | Change in Renal function from baseline (SAD) | Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline | Initiation of dosing through 24 hours post dose | |
Primary | Change in Renal function from baseline (MAD) | Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline | Initiation of dosing on Day 1 through 24 hours and initiation of dosing on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: AUC-last (SAD) | Area under the plasma concentration time curve (AUC) from time zero until the last measurable concentration of CT-1500 is observed during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: AUC-last (SAD) | Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1517 is observed during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: AUC-last (SAD) | Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1518 is observed during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: AUC-last (MAD) | Area under the plasma concentration time curve from time zero until the last measurable concentration of CT-1500 is observed during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: AUC-last (MAD) | Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1517 is observed during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: AUC-last (MAD) | Area under the plasma concentration time curve from time zero until the last measurable concentration of metabolite CT-1518 is observed during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: AUC-inf (SAD) | Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: AUC-inf (MAD) | Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: Cmax (SAD) | Maximal measured plasma concentration (Cmax) of CT-1500 during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: Cmax (SAD) | Maximal measured plasma concentration of metabolite CT-1517 during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: Cmax (SAD) | Maximal measured plasma concentration of metabolite CT-1518 during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: Cmax (MAD) | Maximal measured plasma concentration of CT-1500 during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: Cmax (MAD) | Maximal measured plasma concentration of metabolite CT-1517 during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: Cmax (MAD) | Maximal measured plasma concentration of metabolite CT-1518 during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: Tmax (SAD) | Time when Maximal measured plasma concentration is observed (Tmax) of CT-1500 during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: Tmax (SAD) | Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: Tmax (SAD) | Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the SAD part of the study | Baseline (predose) through 48 hours post dose | |
Secondary | Pharmacokinetic parameter: Tmax (MAD) | Time when Maximal measured plasma concentration is observed of CT-1500 during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: Tmax (MAD) | Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours | |
Secondary | Pharmacokinetic parameter: Tmax (MAD) | Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the MAD part of the study | Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours |
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