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

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03918967
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 4
• Actual Duration (Months): 14
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: CT-G11; Drug: CT-G20; Drug: CT-G11 Placebo; Drug: CT-G20 Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Apr 8, 2019
• Actual Primary Completion Date: Jun 6, 2020
• Actual Study Completion Date: Jun 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-G11 CT-G11 Experimental Drug	Drug: CT-G11; oral tablet of CT-G11 Experimental Drug
Experimental: CT-G20 CT-G20 Experimental Drug	Drug: CT-G20; oral tablet of CT-G20 Experimental Drug
Placebo Comparator: CT-G11 Placebo	Drug: CT-G11 Placebo; oral tablet of Placebo
Placebo Comparator: CT-G20 Placebo	Drug: CT-G20 Placebo; oral tablet of Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse events including serious Adverse events (Part I, Part II) [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) [Up to 48 hours after administration]

Secondary Outcome Measures

1. Safety parameters as assessed by: QT interval of ECG [17 Days]

2. Safety parameters as assessed by: QTcF of ECG [17 Days]

3. Safety parameters as assessed by: blood pressure of Vital signs [17 Days]

4. Safety parameters as assessed by: pulse rate of Vital signs [17 Days]

5. Safety parameters as assessed by: body temperature of Vital signs [17 Days]

6. Safety parameters as assessed by: hematology of Clinical laboratory tests [17 Days]

7. Safety parameters as assessed by: clinical chemistry [17 Days]

8. PK parameters as assessed by : Area under the concentration-time curve (AUC) [13 Days]

9. PK parameters as assessed by : Maximum observed concentration (Cmax) [13 Days]

10. PK parameters as assessed by : Time to Cmax (tmax) [13 Days]

11. PK parameters as assessed by : Terminal half-life time (t1/2) [13 Days]

12. PD parameters as assessed by : Left ventricular ejection fraction (LVEF) [17 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Celltrion

Investigators

• Principal Investigator: In-Jin Jang, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT03918967
• Other Study ID Numbers: CT-G20 1.1
• First Posted: Apr 18, 2019
• Last Update Posted: Jun 9, 2020
• Last Verified: Jun 1, 2020

• 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 Jun 9, 2020