Healthy VolunteersPhase 1NCT02254369
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects
A Phase 1 study testing GC021109 in people with Healthy Volunteers, run by GliaCure, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GC021109
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- Positive urine cotinine at screening.
- Positive results at screening for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.
- Orthostatic vital sign results as deemed clinically significant in the opinion of the PI at screening.
- QTcB interval is >430 msec (males) or >450 msec (females) or deemed clinically abnormal by the PI, prior to dosing of study drug.
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, vitamin supplements or substrates of CYP1A2, CYP3B6, or CYP3A4 beginning 14 days prior to dosing of study drug and throughout the study. Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.
- Any drugs known to be significant inducers of CYP enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing of study drug and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/PD interaction with study drug.
- Has been on a diet incompatible with the on-study diet, in the opinion of the PI, within the 28 days prior to dosing of study drug, and throughout the study.
- Has donated blood within 3 months of screening visit or plans to donate blood within 3 months of study completion, except for blood collected during another clinical trial performed 30 days prior to screening.
- Plasma donation within 7 days prior to dosing of study drug.
- Participation in another clinical trial within 30 days prior to screening. The 30-day window will be derived from the date of the last study scheduled blood collection or dosing, whichever is later, in the previous study to the date of screening for the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Phase 1, Double-Blind, Placebo-Controlled, First-in-Human, Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects
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
- Being tested
- GC021109, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC021109Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1- GC021109 | Experimental | single dose, 0.0014 mg/kg GC021109 Receives: Drug: GC021109 |
| Cohort 2- GC021109 | Experimental | single dose, 0.014 mg/kg GC021109 Receives: Drug: GC021109 |
| Cohort 3-GC021109 | Experimental | single dose, 0.14 mg/kg GC021109 Receives: 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. Receives: Drug: GC021109 |
| Cohort 5- GC021109 | Experimental | single dose, 4.2 mg/kg GC021109 Receives: Drug: GC021109 |
| Cohort 1- placebo | Placebo comparator | single dose, 0.0014 mg/kg matching placebo Receives: Other: Placebo |
| Cohort 2- placebo | Placebo comparator | single dose, 0.014 mg/kg matching placebo Receives: Other: Placebo |
| Cohort 3- placebo | Placebo comparator | single dose, 0.14 mg/kg matching placebo Receives: 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. Receives: Other: Placebo |
| Cohort 5- placebo | Placebo comparator | single dose, 4.2 mg/kg matching placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of TEAEs
Measured: following single dosage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GliaCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254369
- Sponsor's protocol ID
- GC-100-01
- Status last verified
- Feb 2015
- First submitted
- 29 Sep 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 1, Double-Blind, Placebo-Controlled, First-in-Human, Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Doses of GC021109 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02254369
- Acronym / sponsor ID
- GC-100-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- GliaCure, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- GC021109 | Experimental | Drug: GC021109single dose, 0.0014 mg/kg GC021109 |
| Cohort 2- GC021109 | Experimental | Drug: GC021109single dose, 0.014 mg/kg GC021109 |
| Cohort 3-GC021109 | Experimental | Drug: GC021109single dose, 0.14 mg/kg GC021109 |
| Cohort 4- GC021109 | Experimental | Drug: GC021109single 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. |
| Cohort 5- GC021109 | Experimental | Drug: GC021109single dose, 4.2 mg/kg GC021109 |
| Cohort 1- placebo | Placebo comparator | Other: Placebosingle dose, 0.0014 mg/kg matching placebo |
| Cohort 2- placebo | Placebo comparator | Other: Placebosingle dose, 0.014 mg/kg matching placebo |
| Cohort 3- placebo | Placebo comparator | Other: Placebosingle dose, 0.14 mg/kg matching placebo |
| Cohort 4- placebo | Placebo comparator | Other: Placebosingle 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. |
| Cohort 5- placebo | Placebo comparator | Other: Placebosingle dose, 4.2 mg/kg matching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Number and severity of TEAEs
Time frame: following single dosage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC021109 in people with Healthy Volunteers, run by GliaCure, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of TEAEs (time frame: following single dosage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.