First in Human Study of CT-1500 in Healthy Participants

NCT05070702 | Completed Phase 1 DMC

• 1 other identifier: CT-1500-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• Tolerability of CT-1500 as defined by change from baseline in Heart Rate (SAD)

  Initiation of dosing through 7 days post dose

• Tolerability of CT-1500 as defined by change from baseline in Heart Rate (MAD)

  Initiation of dosing through 14 days post dose

• Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (SAD)

  Initiation of dosing through 7 days post dose

• Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (MAD)

  Initiation of dosing through 14 days post dose

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (20)

• Pharmacokinetic parameter: AUC-last (SAD)

  Baseline (predose) through 48 hours post dose

• Pharmacokinetic parameter: AUC-last (SAD)

  Baseline (predose) through 48 hours post dose

• Pharmacokinetic parameter: AUC-last (SAD)

  Baseline (predose) through 48 hours post dose

• Pharmacokinetic parameter: AUC-last (MAD)

  Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours

• Pharmacokinetic parameter: AUC-last (MAD)

  Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours

Study Arms (4)

CT-1500 Active (SAD)

EXPERIMENTAL

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

Drug: CT-1500

Placebo (SAD)

PLACEBO COMPARATOR

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

Drug: Placebo

CT-1500 Active (MAD)

EXPERIMENTAL

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

Drug: CT-1500

Placebo (MAD)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CT-1500 DRUG

Hard Capsule

CT-1500 Active (MAD); CT-1500 Active (SAD)

Placebo DRUG

Hard Capsule

Placebo (MAD); Placebo (SAD)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Circadian Therapeutics Ltd: lead
• Neuroscience Trials Australia: collaborator

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

Study Officials

• Philip Ryan, Dr

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active and Placebo capsules are identical in appearance.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Ascending Single Doses followed by Ascending Multiple Doses of Study Intervention

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 7, 2021
• Study Start: November 8, 2021
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

AU (1)