A Safety and PK Study of EC-18 in Healthy Subjects

NCT02496143 | Completed Phase 1

• 1 other identifier: EC-18-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.

Conditions

Chemotherapy-induced Neutropenia

Keywords

Healthy Volunteers; Phase I; Placebo controlled; Single Ascending Dose; PK; Oral administration; Softgel

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of EC-18 and placebo.

  30 days

Secondary Outcomes (1)

• To determine the composite pharmacokinetic (PK) parameters of EC-18 following sngle oral doses. AUC0-t, AUC0-24, Cmax, Tmax, 48-hour time period.

  Predose [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 hours post dose

Other Outcomes (4)

• To determine the pharmacodynamic effects of EC-18 on circulating leukocyte cell counts.

  Day 5 after dosing.

• To determine the pharmacodynamic effects of EC-18 on red blood cell counts.

  Day 5 after dosing.

• To determine the pharmacodynamic effects of EC-18 on reticulocyte counts.

  Day 5 after dosing.

Study Arms (4)

Cohort 1

EXPERIMENTAL

500 mg EC-18 dose or placebo

Drug: EC-18; Drug: Placebo

Cohort 2

EXPERIMENTAL

1000 mg EC-18 dose orplacebo

Drug: EC-18; Drug: Placebo

Cohort 3

EXPERIMENTAL

2000 mg EC-18 dose or placebo

Drug: EC-18; Drug: Placebo

Cohort 4

EXPERIMENTAL

4000 mg EC-18 dose or placebo

Drug: EC-18; Drug: Placebo

Interventions

EC-18 DRUG

EC-18 will be supplied as 500 mg Softgel capsules. The study will include up to four sequential dose cohorts. Six subjects in each cohort will be randomized to receive EC-18: 500, 1000, 2000, or 4000 mg by oral administration of 1, 2, 4, and 8 EC-18 capsules, for Cohorts 1, 2, 3 or 4, respectively.

Also known as: EC-18 Softgel capsule

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Placebo DRUG

Placebo will be supplied as Softgel capsules. The study will include up to four sequential dose cohorts. Two subjects in each cohort will be randomized to placebo and will receive 1, 2, 4 or 8 placebo capsules for Cohorts 1, 2, 3 or 4, respectively.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females of childbearing potential must use an acceptable birth control method throughout the study and for 14 days after the dose of study drug.
• Females of non-childbearing potential (defined as surgically sterilized \[tubal ligation/hysterectomy/bilateral salpingo-oophorectomy\] or postmenopausal for \>2 years) with a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.
• Males willing to practice contraception (condom + spermicide) during the study and for 14 days after completion of the study, or who have a female partner using barrier or oral contraception during that timeframe.
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
• Ability to understand and give informed consent and provide authorization for use of protected health information (Health Insurance Portability and Accountability Act).
• Willing and able to be confined to the research clinic as required by the protocol.

You may not qualify if:

• Febrile (temperature ≥99.5°F/37.5°C) at the Screening Visit or at admission to the research clinic on Day -1.
• Clinically significant laboratory findings at the Screening Visit defined as the following:
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin \>1.5 x upper limit of normal (ULN)
• Blood urea nitrogen (BUN), creatinine \>1.25 x ULN
• White blood cell (WBC) count \<0.9 x lower limit of normal (LLN) or \>1.1 x ULN
• Hemoglobin or hematocrit \<0.9 x LLN or \>1.1 x ULN
• Platelet count \<0.9 x LLN or \>1.1 x ULN
• Glucose \<0.9 x LLN or \>1.25 x ULN
• Thyroid-stimulating hormone (TSH) \<0.75 x LLN or \>1.25 x ULN or any other laboratory, ECG, vital sign, or physical abnormality that, in the investigator's opinion, unfavorably increases the risk of study participation.
• Positivity for human immunodeficiency virus (HIV) or receiving active antiretroviral therapy, hepatitis B surface antigen positivity, or hepatitis C positivity.
• History of drug or alcohol abuse within the past 2 years.
• Females who are pregnant or intend to get pregnant over the next month.
• Positive urine pregnancy test at the Screening Visit or at admission to the research clinic on Day -1.
• Positive urine drug or breath alcohol test at the Screening Visit or at admission to the research clinic on Day -1. Subjects should be instructed not to drink alcohol within 12 hours of the screening assessment.
• Intake of alcohol within 72 hours prior to study drug administration or intake of grapefruit or Seville oranges within 7 days prior to the administration of study drug.

Sponsors & Collaborators

• Enzychem Lifesciences Corporation: lead

Study Sites (1)

Carolina Phase I Clinical Research

Raleigh, North Carolina, 27612, United States

Location

Study Officials

• Treva W Tyson, MD

  Wake Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)