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Completed

NCT Number: NCT03918967

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 or CT-G11 and Food Effect of CT-G20 in Human Participants

The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20 or CT-11 and to evaluate potential effect of food on pharmacokinetics of CT-G20 in human participants. It will be conducted in three parts, as described below:

* Part I will be a randomized, double-blind, placebo-controlled, sequential, single ascending dose study. * Part II will be a randomized, double-blind, placebo-controlled, sequential, multiple ascending dose study. * Part III will be a randomized, open-label, balanced, two-period, two-sequence crossover, food effect study.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index (BMI) ≥18.0 and ≤30.0 kg/m2

Exclusion criteria

  • Clinically significant allergic reactions
  • Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
  • Hepatic dysfunction upper limit of normal laboratory range
  • Cardiac history or presence
  • History or any concomitant active malignancy
  • A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Inherited bleeding diathesis or coagulopathy with the risk of bleeding
  • Hemoptysis, thrombotic or hemorrhagic event
  • Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
  • History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
  • Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption

Treatment and study plan

CT-G11

Drug

oral tablet of CT-G11 Experimental Drug

CT-G20

Drug

oral tablet of CT-G20 Experimental Drug

CT-G11 Placebo

Drug

oral tablet of Placebo

CT-G20 Placebo

Drug

oral tablet of Placebo

Primary outcomes

  1. Incidence of Adverse events including serious Adverse events (Part I, Part II)

    Time frame: 46 days

  2. Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)

    Time frame: Up to 48 hours after administration

Secondary outcomes

  1. Safety parameters as assessed by: QT interval of ECG

    Time frame: 17 Days

  2. Safety parameters as assessed by: QTcF of ECG

    Time frame: 17 Days

  3. Safety parameters as assessed by: blood pressure of Vital signs

    Time frame: 17 Days

  4. Safety parameters as assessed by: pulse rate of Vital signs

    Time frame: 17 Days

  5. Safety parameters as assessed by: body temperature of Vital signs

    Time frame: 17 Days

  6. Safety parameters as assessed by: hematology of Clinical laboratory tests

    Time frame: 17 Days

  7. Safety parameters as assessed by: clinical chemistry

    Time frame: 17 Days

  8. PK parameters as assessed by : Area under the concentration-time curve (AUC)

    Time frame: 13 Days

  9. PK parameters as assessed by : Maximum observed concentration (Cmax)

    Time frame: 13 Days

  10. PK parameters as assessed by : Time to Cmax (tmax)

    Time frame: 13 Days

  11. PK parameters as assessed by : Terminal half-life time (t1/2)

    Time frame: 13 Days

  12. PD parameters as assessed by : Left ventricular ejection fraction (LVEF)

    Time frame: 17 Days

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study title

A Two-segment Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G11 and CT-G20 in Healthy Volunteers (Part 1 and Part 2) and Open Label, Balanced, Randomized, Two-period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of CT-G20 in Healthy Volunteers (Part 3)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2019
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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