First in Human Study of CT-1500 in Healthy Participants

Sponsor
Circadian Therapeutics Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05070702
Collaborator
Neuroscience Trials Australia (Other)
64
Enrollment
1
Location
4
Arms
7.3
Anticipated Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Detailed 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 1250 mg. Three dose levels are proposed for investigation in the multiple ascending dose (MAD) part (Part 2) of the study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Ascending Single Doses followed by Ascending Multiple Doses of Study InterventionAscending Single Doses followed by Ascending Multiple Doses of Study Intervention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Active and Placebo capsules are identical in appearance.
Primary Purpose:
Other
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
Anticipated Study Start Date :
Oct 20, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: CT-1500 Active (SAD)

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
Hard Capsule

Placebo Comparator: Placebo (SAD)

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
Hard Capsule

Experimental: CT-1500 Active (MAD)

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
Hard Capsule

Placebo Comparator: Placebo (MAD)

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
Hard Capsule

Outcome Measures

Primary Outcome Measures

  1. Adverse Events (AEs) and Serious Adverse Events (SAEs) during the SAD part of the study [Initiation of dosing through 96 hours post dose]

    Incidence and severity of AEs and SAEs

  2. Adverse Events and Serious Adverse Events during the MAD part of the study [Initiation of dosing through 14 days post dose]

    Incidence and severity of AEs and SAEs

  3. Tolerability of CT-1500 as defined by change from baseline in Heart Rate (SAD) [Initiation of dosing through 96 hours post dose]

  4. Tolerability of CT-1500 as defined by change from baseline in Heart Rate (MAD) [Initiation of dosing through 14 days post dose]

  5. Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (SAD) [Initiation of dosing through 96 hours post dose]

  6. Tolerability of CT-1500 as defined by change from baseline in Respiratory Rate (MAD) [Initiation of dosing through 14 days post dose]

  7. Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram Assessment (SAD) [Initiation of dosing through 96 hours post dose]

    Change in QT interval from baseline

  8. Tolerability of CT-1500 as defined by change from baseline in Electrocardiogram assessment (MAD) [Initiation of dosing through 14 days post dose]

    Change in QT interval from baseline

  9. Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (SAD) [Initiation of dosing through 96 hours post dose]

    Change from baseline in Forced Expiratory Volume in 1 second (FEV1)

  10. Tolerability of CT-1500 as defined by change from baseline in Spirometry assessment (MAD) [Initiation of dosing through 14 days post dose]

    Change from baseline in Forced Expiratory Volume in 1 second (FEV1)

  11. Change in Renal function from baseline (SAD) [Initiation of dosing through 24 hours post dose]

    Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline

  12. Change in Renal function from baseline (MAD) [Initiation of dosing on Day 1 through 24 hours and initiation of dosing on Day 7 through 24 hours]

    Renal Function as assessed by change in estimated Glomerular Filtration Rate from baseline

Secondary Outcome Measures

  1. Pharmacokinetic parameter: AUC-last (SAD) [Baseline (predose) through 24 hours post dose]

    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

  2. Pharmacokinetic parameter: AUC-last (SAD) [Baseline (predose) through 24 hours post dose]

    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

  3. Pharmacokinetic parameter: AUC-last (SAD) [Baseline (predose) through 24 hours post dose]

    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

  4. Pharmacokinetic parameter: AUC-last (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    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

  5. Pharmacokinetic parameter: AUC-last (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    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

  6. Pharmacokinetic parameter: AUC-last (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    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

  7. Pharmacokinetic parameter: AUC-inf (SAD) [Baseline (predose) through 24 hours post dose]

    Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the SAD part of the study

  8. Pharmacokinetic parameter: AUC-inf (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    Area under the plasma concentration time curve from time zero to infinity of CT-1500 is observed during the MAD part of the study

  9. Pharmacokinetic parameter: Cmax (SAD) [Baseline (predose) through 24 hours post dose]

    Maximal measured plasma concentration (Cmax) of CT-1500 during the SAD part of the study

  10. Pharmacokinetic parameter: Cmax (SAD) [Baseline (predose) through 24 hours post dose]

    Maximal measured plasma concentration of metabolite CT-1517 during the SAD part of the study

  11. Pharmacokinetic parameter: Cmax (SAD) [Baseline (predose) through 24 hours post dose]

    Maximal measured plasma concentration of metabolite CT-1518 during the SAD part of the study

  12. Pharmacokinetic parameter: Cmax (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    Maximal measured plasma concentration of CT-1500 during the MAD part of the study

  13. Pharmacokinetic parameter: Cmax (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    Maximal measured plasma concentration of metabolite CT-1517 during the MAD part of the study

  14. Pharmacokinetic parameter: Cmax (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    Maximal measured plasma concentration of metabolite CT-1518 during the MAD part of the study

  15. Pharmacokinetic parameter: Tmax (SAD) [Baseline (predose) through 24 hours post dose]

    Time when Maximal measured plasma concentration is observed (Tmax) of CT-1500 during the SAD part of the study

  16. Pharmacokinetic parameter: Tmax (SAD) [Baseline (predose) through 24 hours post dose]

    Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the SAD part of the study

  17. Pharmacokinetic parameter: Tmax (SAD) [Baseline (predose) through 24 hours post dose]

    Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the SAD part of the study

  18. Pharmacokinetic parameter: Tmax (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    Time when Maximal measured plasma concentration is observed of CT-1500 during the MAD part of the study

  19. Pharmacokinetic parameter: Tmax (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    Time when Maximal measured plasma concentration is observed of metabolite CT-1517 during the MAD part of the study

  20. Pharmacokinetic parameter: Tmax (MAD) [Baseline (predose) on Day 1 through 24 hours post dose and Baseline (predose) on Day 7 through 24 hours]

    Time when Maximal measured plasma concentration is observed of metabolite CT-1518 during the MAD part of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Generally healthy with the exception of those medical conditions allowed per the study criteria

  • 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

  • Women of childbearing potential must have a negative serum pregnancy test and 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

  • Positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (HCV) or positive human immunodeficiency virus (HIV) test

  • 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Nucleus NetworkMelbourneVictoriaAustralia3004

Sponsors and Collaborators

  • Circadian Therapeutics Ltd
  • Neuroscience Trials Australia

Investigators

  • Principal Investigator: Ben Snyder, Dr, Nucleus Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Circadian Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT05070702
Other Study ID Numbers:
  • CT-1500-01
First Posted:
Oct 7, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 7, 2021