Healthy VolunteersPhase 1NCT01954238
A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers
A Phase 1 study testing GCC-4401C and Rivaroxaban in people with Healthy Volunteers, run by Green Cross Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GCC-4401C and Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject voluntarily has agreed to participate in this study and signed an Institutional Review Board (IRB)-approved informed consent before any of the Screening procedures will be performed.
- Males between 18 to 45 years of age, inclusive, at Screening.
- Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past month prior to screening) and by urine cotinine concentration (< 400 ng/mL) at Screening.
- Body mass index (BMI) between 18.5 and 28.0 kg/m2 at Screening.
- Healthy, determined by pre-study medical evaluation and Investigator/designee discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).
Who cannot join
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Have any of the following, which may put them at increased risk with anticoagulant use: family history or personal history of bleeding disorders or diseases/syndromes that can either alter or increase the propensity for bleeding; any other contraindication to anticoagulant treatment, or increased bleeding risk, as judged by the Investigator.
- Are considering or scheduled to undergo any surgical procedure during the study.
- Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
- Fecal occult blood positive test at screening and admission.
Show all 26Show fewer
- Subject has history of alcohol and/or illicit drug abuse within one year of the Screening visit.
- Positive Screening test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody.
- Positive alcohol breathalyzer test at Screening or Day -1.
- Positive urine drug test (cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids, etc.) at Screening or Day -1.
- Subject unwilling to avoid consumption of coffee and caffeine containing beverages within 48 hours prior to Day -1 until discharge from the clinical site.
- Subject unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to Day -1 until discharge from the clinical site.
- Donation of blood (> 500 mL) or blood products within 2 months (56 days) prior to Day -1.
- Use of over-the-counter (OTC) medications, prescription medications, or herbal remedies from 14 days or 5 time their half-lives whatever is more, prior to Day -1 and vitamin from 7 days prior to Day -1, until End-of-Study. By exception, acetaminophen 1000 mg per day is permitted.
- Use of any drugs that induce or inhibit cytochrome P450 or P-glycoprotein within 30 days prior to dosing.
- Any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of dosing.
- Use of an investigational drug within 30 days prior to Day 1.
- Unwilling to abstain from vigorous exercise from 48 hours prior to Day -1 until End-of-Study.
- Subject has a history of hypersensitivity to the investigational medicinal products (IMPs) or any of the excipients or to medicinal products with similar chemical structures.
- Planning to father a child or donate sperm during the study and within 3 months following dosing.
- Subject does not have veins suitable for cannulation or multiple venipunctures.
- Subject is unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.
- Subject is unlikely to comply with the protocol requirements, instructions and study related restrictions; e.g., uncooperative attitude, inability to return for Follow-up visits and improbability of completing the clinical study.
- Subject has previously been enrolled in this clinical study.
- Subjects involved in the planning or conduct of this clinical study.
- Vulnerable subject (e.g. kept in detention)
Trial locations and contacts
1 site in 1 country.
United States1 site
PAREXEL Internatonal
Early Phase Clinical Unit _Los Angeles, California, CA 91206
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Sequential Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GCC-4401C in Healthy Males
The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.
Read the detailed description
The primary objective is to investigate the safety, tolerability, and pharmacokinetics of multiple doses of GCC-4401C in healthy male subjects.
Forty-six subjects are planned for enrollment. The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort. In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion. Within each of the five cohorts, six subjects will be randomized to GCC-4401C and two subjects will be randomized to placebo.
The secondary objectives of this study are
- To characterize the single dose safety, tolerability, and PK after oral administration of GCC-4401C in healthy male subjects.
- To characterize the multiple dose pharmacodynamics after oral administration of GCC-4401C in healthy male subjects.
- To determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials.
- To compare the PK and PD of GCC-4401C with an active rivaroxaban (Xarelto®)group at 20 mg in healthy male subjects.
- Conditions
- Healthy Volunteers
- Being tested
- GCC-4401C, Rivaroxaban, Placebo
- Keywords
- Anti-coagulant, Coagulation factor Xa inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCC-4401CDrug
Also called Nokxaban
- Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease.
- The dose selection for this clinical study was based on the safety, Pharmacokinetics and Pharmacodynamics results of the single dose study.
- GCC-4401C was well tolerated in the single ascending dose study up to the highest single oral dose administered of 80 mg from 2.5 mg in 48 subjects.
- The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort.
- In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion.
RivaroxabanDrug
Also called Xarelto
Rivaroxaban (Xarelto®) 20 mg tablets for oral administration IMP, placebo and comparator will be administered the same time points. The comparator will be administered open-label 30 minutes after a standard breakfast.
PlaceboDrug
Also called GCC-4401C matching placebo
GCC-4401C matching placebo(Capsule): Strength is not applicable. GCC-4401C and placebo will be administered double-blind after a 10 hours fast.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Active comparator | Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease Receives: Drug: GCC-4401C |
| Placebo | Placebo comparator | GCC-4401C matching placebo capsule Receives: Drug: GCC-4401C |
| GCC-4401C | Experimental | Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease. It is a novel molecule with a structural similarity to Rivaroxaban. Receives: Drug: Rivaroxaban; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of GCC-4401C when repeatedly administered to healthy male adults
The following safety parameters will be recorded at regular intervals during the clinical study_
- Vital signs (supine blood pressure (BP) and pulse, oral body temperature, respiratory rate (RR))
- Twelve-lead ECG
- 24-hour telemetry
- Clinical laboratory testing (hematology, clinical chemistry, coagulation and urinalysis)
- Hemoccult test
- Adverse event assessments
- Concomitant medication assessments
- Physical examinations
Measured: Up to 17 ~ 19 days after administration
Secondary outcomes (1)
The Pharmacokinetics (PK) of GCC-4401C when repeatedly administered to healthy male adults
The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort. In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion. Subjects will undergo dosing procedures on the morning of Day 1, and Day 3 to 9.
- The following PK parameters for GCC-4401C and rivaroxaban will be determined after single dose, as appropriate_
- Cmax
- tmax
- λz
- Area under the curve from zero to the time of the last measurable concentration[AUC(0-last)]
- Area under the curve from zero to infinity[AUC(0-inf)]
- t½
- Apparent systemic clearance(CL/F)
- Vz/F
- The following parameters will be determined after repeat treatment for the GCC-4401C and rivaroxaban_
- Trough plasma concentration(Ctrough)
- Cmax,ss,
- Cmin,ss,
- tmax,ss,
- λz,ss,
- AUC(0 τ),ss,
- t½,ss,
- CL
Measured: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose on Day 1 and Day 9 and at pre dose on Days 5 through 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2014
- Study completionMay 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- David Han, M.D., Principal investigator, California Clinical Trials Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954238
- Sponsor's protocol ID
- GC2107_102
- Status last verified
- Dec 2014
- First submitted
- 23 Sep 2013
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Sequential Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GCC-4401C in Healthy Males
- ClinicalTrials.gov ID
- NCT01954238
- Acronym / sponsor ID
- GC2107_102
- Conditions
- Healthy Volunteers
- Keywords
- Anti-coagulant, Coagulation factor Xa inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Aug 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Oct 2013 (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 purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.
Detailed description
The primary objective is to investigate the safety, tolerability, and pharmacokinetics of multiple doses of GCC-4401C in healthy male subjects.
Forty-six subjects are planned for enrollment. The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort. In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion. Within each of the five cohorts, six subjects will be randomized to GCC-4401C and two subjects will be randomized to placebo.
The secondary objectives of this study are
- To characterize the single dose safety, tolerability, and PK after oral administration of GCC-4401C in healthy male subjects.
- To characterize the multiple dose pharmacodynamics after oral administration of GCC-4401C in healthy male subjects.
- To determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials.
- To compare the PK and PD of GCC-4401C with an active rivaroxaban (Xarelto®)group at 20 mg in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Active comparator | Drug: GCC-4401COrally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease |
| Placebo | Placebo comparator | Drug: GCC-4401CGCC-4401C matching placebo capsule |
| GCC-4401C | Experimental | Drug: Rivaroxaban, Drug: PlaceboOrally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease. It is a novel molecule with a structural similarity to Rivaroxaban. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject voluntarily has agreed to participate in this study and signed an Institutional Review Board (IRB)-approved informed consent before any of the Screening procedures will be performed.
- Males between 18 to 45 years of age, inclusive, at Screening.
- Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past month prior to screening) and by urine cotinine concentration (< 400 ng/mL) at Screening.
- Body mass index (BMI) between 18.5 and 28.0 kg/m2 at Screening.
- Healthy, determined by pre-study medical evaluation and Investigator/designee discretion (medical history, physical examination, vital signs, ECG, and clinical laboratory evaluations).
Key exclusion criteria (26 listed)
- Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator/designee.
- Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Have any of the following, which may put them at increased risk with anticoagulant use: family history or personal history of bleeding disorders or diseases/syndromes that can either alter or increase the propensity for bleeding; any other contraindication to anticoagulant treatment, or increased bleeding risk, as judged by the Investigator.
- Are considering or scheduled to undergo any surgical procedure during the study.
- Any concurrent disease or condition that, in the opinion of the Investigator/designee, would make the subject unsuitable for participation in the clinical study.
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 |
|---|---|---|
| GCC-4401CAlso: Nokxaban* Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease. * The dose selection for this clinical study was based on the safety, Pharmacokinetics and Pharmacodynamics results of the single dose study. * GCC-4401C was well tolerated in the single ascending dose study up to the highest single oral dose administered of 80 mg from 2.5 mg in 48 subjects. * The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort. * In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion. | Drug | Placebo, Rivaroxaban |
| RivaroxabanAlso: XareltoRivaroxaban (Xarelto®) 20 mg tablets for oral administration IMP, placebo and comparator will be administered the same time points. The comparator will be administered open-label 30 minutes after a standard breakfast. | Drug | GCC-4401C |
| PlaceboAlso: GCC-4401C matching placeboGCC-4401C matching placebo(Capsule): Strength is not applicable. GCC-4401C and placebo will be administered double-blind after a 10 hours fast. | Drug | GCC-4401C |
Primary outcome
The safety of GCC-4401C when repeatedly administered to healthy male adults
Time frame: Up to 17 ~ 19 days after administration
The following safety parameters will be recorded at regular intervals during the clinical study_ * Vital signs (supine blood pressure (BP) and pulse, oral body temperature, respiratory rate (RR)) * Twelve-lead ECG * 24-hour telemetry * Clinical laboratory testing (hematology, clinical chemistry, coagulation and urinalysis) * Hemoccult test * Adverse event assessments * Concomitant medication assessments * Physical examinations
1 secondary outcome
The Pharmacokinetics (PK) of GCC-4401C when repeatedly administered to healthy male adults
Time frame: Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post dose on Day 1 and Day 9 and at pre dose on Days 5 through 8
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 23 Dec 2014.
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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.
David Han, M.D. principal investigator
California Clinical Trials Medical Group
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 GCC-4401C and Rivaroxaban in people with Healthy Volunteers, run by Green Cross Corporation 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 5 inclusion and 26 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 23 Dec 2014. 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?
The safety of GCC-4401C when repeatedly administered to healthy male adults (time frame: Up to 17 ~ 19 days after administration). 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 23 Dec 2014.