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

Healthy Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918967
• Other study ID #: CT-G20 1.1
• Status: Completed
• Phase: Phase 1
• Start date: April 8, 2019
• Est. completion date: June 6, 2020

Study information

• Verified date: June 2020
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 6, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CT-G11
oral tablet of CT-G11 Experimental Drug
• CT-G20
oral tablet of CT-G20 Experimental Drug
• CT-G11 Placebo
oral tablet of Placebo
• CT-G20 Placebo
oral tablet of Placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse events including serious Adverse events (Part I, Part II)		46 days
Primary	Food effect as assessed by : PK parameters including Area under the concentration-time curve (AUC) and Maximum observed concentration (Cmax) (Part III)		Up to 48 hours after administration
Secondary	Safety parameters as assessed by: QT interval of ECG		17 Days
Secondary	Safety parameters as assessed by: QTcF of ECG		17 Days
Secondary	Safety parameters as assessed by: blood pressure of Vital signs		17 Days
Secondary	Safety parameters as assessed by: pulse rate of Vital signs		17 Days
Secondary	Safety parameters as assessed by: body temperature of Vital signs		17 Days
Secondary	Safety parameters as assessed by: hematology of Clinical laboratory tests		17 Days
Secondary	Safety parameters as assessed by: clinical chemistry		17 Days
Secondary	PK parameters as assessed by : Area under the concentration-time curve (AUC)		13 Days
Secondary	PK parameters as assessed by : Maximum observed concentration (Cmax)		13 Days
Secondary	PK parameters as assessed by : Time to Cmax (tmax)		13 Days
Secondary	PK parameters as assessed by : Terminal half-life time (t1/2)		13 Days
Secondary	PD parameters as assessed by : Left ventricular ejection fraction (LVEF)		17 Days