Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects

NCT02254369 | Completed Phase 1

• 1 other identifier: GC-100-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to assess the safety and tolerability of single oral doses of GC021109 when administered to healthy adult subjects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number and severity of TEAEs

  following single dosage

Study Arms (10)

Cohort 1- GC021109

EXPERIMENTAL

single dose, 0.0014 mg/kg GC021109

Drug: GC021109

Cohort 2- GC021109

EXPERIMENTAL

single dose, 0.014 mg/kg GC021109

Drug: GC021109

Cohort 3-GC021109

EXPERIMENTAL

single dose, 0.14 mg/kg GC021109

Drug: GC021109

Cohort 4- GC021109

EXPERIMENTAL

single dose, 1.4 mg/kg GC021109 subjects will receive GC021109 under fasting then under fed conditions separated by a washout of 14 (± 1) days after the first dose.

Drug: GC021109

Cohort 5- GC021109

EXPERIMENTAL

single dose, 4.2 mg/kg GC021109

Drug: GC021109

Cohort 1- placebo

PLACEBO COMPARATOR

single dose, 0.0014 mg/kg matching placebo

Other: Placebo

Cohort 2- placebo

PLACEBO COMPARATOR

single dose, 0.014 mg/kg matching placebo

Other: Placebo

Cohort 3- placebo

PLACEBO COMPARATOR

single dose, 0.14 mg/kg matching placebo

Other: Placebo

Cohort 4- placebo

PLACEBO COMPARATOR

single dose, 1.4 mg/kg subjects will receive matching placebo under fasting then under fed conditions separated by a washout of 14 (+/- 1) days after the first dose.

Other: Placebo

Cohort 5- placebo

PLACEBO COMPARATOR

single dose, 4.2 mg/kg matching placebo

Other: Placebo

Interventions

GC021109 DRUG

Cohort 1- GC021109; Cohort 2- GC021109; Cohort 3-GC021109; Cohort 4- GC021109; Cohort 5- GC021109

Placebo OTHER

Cohort 1- placebo; Cohort 2- placebo; Cohort 3- placebo; Cohort 4- placebo; Cohort 5- placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male and/or non-childbearing potential females, 18 to 55 years of age, inclusive, at the time of informed consent.
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to dosing of study drug.
• BMI ≥ 18.5 and ≤ 32.0 (kg/m2) at screening with a maximum weight of 120 kg.
• Medically healthy with no clinically significant screening results that would exclude subject from the study as deemed by the PI.
• Females must have undergone 1 of the following sterilization procedures, and have official documentation, at least 6 months prior to dosing of study drug:
• Hysteroscopic sterilization
• Bilateral tubal ligation or bilateral salpingectomy
• Hysterectomy.
• Bilateral oophorectomy. OR be postmenopausal with amenorrhea for at least 1 year prior to dosing of study drug and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status.
• All male subjects must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug.
• If male, must agree to not donate sperm from Day -1 until 90 days after dosing.
• Understand the study procedures in the ICF, and be willing and able to comply with the protocol.

You may not qualify if:

• Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
• History of any illness that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
• History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
• History or presence of hypersensitivity or idiosyncratic reaction to component of the study drug or related compounds.
• History of cancer within the past 5 years (excluding non-melanoma skin cancer) prior to screening.
• Clinically significant abnormal screening laboratory test values (as determined by the
• PI), including, but not limited to, the following:
• any values for alanine aminotransferase (ALT) or aspartate aminotransferase (AST) that are above the upper limit of the reference range at screening or check-in.
• any values for total or direct bilirubin that are 1.5 times above the upper limit of the reference range at screening or check-in.
• estimated creatinine clearance \<90 mL/min at screening only.
• Clinically significant infection within 3 months prior to screening as determined by the PI.
• Female subjects of child-bearing potential.
• Female subjects who are pregnant or lactating.
• Positive urine drug or urine alcohol results at screening or check-in.

Sponsors & Collaborators

• GliaCure, Inc.: lead

Study Sites (1)

Celerion

Neptune City, New Jersey, 07753, United States

Location

Study Design

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

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

US (1)