Healthy MalePhase 1NCT01651234
A Study to Assess Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC4401C in Healthy Volunteers
A Phase 1 study testing GCC-4401 and GCC-4401C in people with Healthy Male, 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 characterize the PK, PD f\profile. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male
- What is being tested?
- GCC-4401 and GCC-4401C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);
- Normal healthy males between 18 and 55 years of age, inclusive, at the time of consent;
- A body mass index (BMI) of at least 18.5 kg/m2 but no more than 30 kg/m2 (BMI is defined as the subject's weight in kilograms divided by the square root of the subject's height in meters);
- In general good health based on screening medical history, physical examination (defined as the absence of any clinically significant abnormalities), vital signs, and clinical laboratory values (hematology, serum chemistry, and urinalysis);
- Have a normal ECG (defined as Fridericia's correction for QT interval [QTcF] less than or equal to 450 ms) at screening, Day -1 and Day 1, predose (baseline). Repeat ECG measurements will be allowed at the baseline assessment for QTcF values above 450 ms and the average will be used to assess eligibility.
- Male subjects must use barrier contraception during sexual intercourse, ie, condoms, from the first day of dosing until 3 months after the last dosing with GCC-4401C; and
- Nonsmokers (defined as not having smoked or used any nicotine containing products for at least 1 month, and having a urine cotinine less than 400 ng/mL).
Who cannot join
- Subjects presenting with any of the following will not be entered into the study:
- Have clinically significant abnormal history, physical findings, or laboratory values at the prestudy screening assessment that could interfere with the objectives of the study or the safety of the subjects;
- 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;
- severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within the past 3 months;
- endoscopic peptic-ulcer disease within the past 3 years or clinically significant gastrointestinal, genitourinary, or gum bleeding within the past 3 months;
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- a personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage; or rectal bleeding within 3 months prior to screening;
- any history of thrombotic or hemorrhagic stroke;
- clinically significant laboratory abnormalities (hemoglobin less than 12.0 g/dL, prolonged PT or INR, prolonged aPTT, elevated liver enzymes, elevated serum creatinine or blood urea nitrogen (BUN) which is considered clinically significant by the Investigator, or platelet count less than 150,000/mm3 or greater than 600,000/mm3). Mildly elevated BUN with normal serum creatinine values which are determined not to be clinical significant by the Investigator are permitted. These significant laboratory values may be repeated for confirmation; or
- any other contraindication to anticoagulant treatment, or increased bleeding risk, as judged by the Investigator.
- Have known positive test for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) 1, or HIV 2;
- Are considering or scheduled to undergo any surgical procedure during the study;
- Have received an investigational product within 30 days prior to dosing;
- Presence or history of severe adverse reaction to any drug;
- Involvement in the planning and/or conduct of the study;
- Positive urine drug screen or urine alcohol screen at medical screening or check-in;
- History of alcohol, drug, or substance abuse, as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition in the past 12 months;
- Positive test result for fecal occult blood, measured at screening and/or at check-in to the clinic;
- Consumption of alcohol within 48 hours prior to dosing;
- Intake of more than 14 units (a unit is 12 oz beer, 5 oz wine, or 1.5 oz liquor) of alcohol per week;
- Use of any drugs that induce or inhibit cytochrome P450 or P-glycoprotein within 30 days prior to dosing;
- Use of any prescribed or over-the-counter (OTC) medications including antacids, analgesics, herbal remedies, vitamins, and minerals (with the exception of up to 3 grams of acetaminophen) or medications containing aspirin or nonsteroidal anti-inflammatory medications with anticoagulant effects within 2 weeks 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;
- Planning to father a child or donate sperm during the study and 3 months following dosing;
- Do not have veins suitable for cannulation or multiple venipunctures;
- Have previously participated in this study;
- Donation of plasma or blood products within 1 month of screening or any blood donation/blood loss greater than 450 mL during the 3 months prior to screening; or
- Any other factor that the Investigator thinks will increase subject risk with participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC-4401C in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability and characterize the PK, PD f\profile.
Read the detailed description
The primary objective of this study is to investigate the safety and tolerability following administration of single ascending doses of GCC4401C in healthy male subjects; and the secondary objective of this study is to characterize the single-dose PK profile after oral administration of GCC-4401C, and to determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials.
- Conditions
- Healthy Male
- Being tested
- GCC-4401, GCC-4401C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCC-4401Drug
- Swedish Orange opaque hard gelatin capsules of size 1 with no markings for oral use
- single dose
- dosage
- Cohort 1: 2.5-mg GCC-4401C
- Cohort 2: 5.0-mg GCC-4401C
- Cohort 3: 10-mg GCC-4401C
- Cohort 4: 20-mg GCC-4401C
- Cohort 5: 40-mg GCC-4401C
- Cohort 6: 80-mg GCC-4401C
GCC-4401CDrug
- Capsule, identical in appearance to GCC-4401C, for oral use
- single dose
- dosage
- Cohort 1: 2.5-mg matching placebo
- Cohort 2: 5.0-mg matching placebo
- Cohort 3: 10-mg matching placebo
- Cohort 4: 20-mg matching placebo
- Cohort 5: 40-mg matching placebo
- Cohort 6: 80-mg matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: GCC-4401 |
| Placebo | Placebo comparator | Not described Receives: Drug: GCC-4401C |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and percentage of subjects experiencing 1 or more AEs will be summarized by treatment/dose group, relationship to study drug, and severity.
Measured: up to 7 ~ 10 days after administraion
Statistics for clinical laboratory data(continuous variables only), vital signs, and ECF intervals will be presented for each evaluation during the study and for change from baseline to postdose evaluations.
Measured: up to 7 ~10 days after administration
Secondary outcomes (1)
the single-dose pharmacokinetic behavior
to characterize the single-dose pharmacokinetic behavior after oral administration of GCC-4401C
- maximum plasma concentration (Cmax);
- time to Cmax (tmax);
- terminal rate constant (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)];
- apparent terminal half-life (t½);
- apparent systemic clearance (CL/F);
- apparent volume of distribution (Vz/F);
- renal clearance (CLr); and
- fraction of drug (fe) excreted unchanged in urine (% of dose).
Measured: at predose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, and 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MaleStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651234
- Sponsor's protocol ID
- GCC4401C-101
- Status last verified
- Aug 2012
- First submitted
- 17 Jul 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Orally Administered GCC-4401C in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01651234
- Acronym / sponsor ID
- GCC4401C-101
- Conditions
- Healthy Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 27 Jul 2012 (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 characterize the PK, PD f\profile.
Detailed description
The primary objective of this study is to investigate the safety and tolerability following administration of single ascending doses of GCC4401C in healthy male subjects; and the secondary objective of this study is to characterize the single-dose PK profile after oral administration of GCC-4401C, and to determine an appropriate dose range and dosing regimen of oral GCC-4401C for subsequent clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: GCC-4401 |
| Placebo | Placebo comparator | Drug: GCC-4401C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Capable of understanding and complying with the requirements of the study and have signed the informed consent form (ICF);
- Normal healthy males between 18 and 55 years of age, inclusive, at the time of consent;
- A body mass index (BMI) of at least 18.5 kg/m2 but no more than 30 kg/m2 (BMI is defined as the subject's weight in kilograms divided by the square root of the subject's height in meters);
- In general good health based on screening medical history, physical examination (defined as the absence of any clinically significant abnormalities), vital signs, and clinical laboratory values (hematology, serum chemistry, and urinalysis);
- Have a normal ECG (defined as Fridericia's correction for QT interval [QTcF] less than or equal to 450 ms) at screening, Day -1 and Day 1, predose (baseline). Repeat ECG measurements will be allowed at the baseline assessment for QTcF values above 450 ms and the average will be used to assess eligibility.
Key exclusion criteria (28 listed)
- Have clinically significant abnormal history, physical findings, or laboratory values at the prestudy screening assessment that could interfere with the objectives of the study or the safety of the subjects;
- Have any of the following, which may put them at increased risk with anticoagulant use:
- Have known positive test for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) 1, or HIV 2;
- Are considering or scheduled to undergo any surgical procedure during the study;
- Have received an investigational product within 30 days prior to dosing;
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-4401* Swedish Orange opaque hard gelatin capsules of size 1 with no markings for oral use * single dose * dosage * Cohort 1: 2.5-mg GCC-4401C * Cohort 2: 5.0-mg GCC-4401C * Cohort 3: 10-mg GCC-4401C * Cohort 4: 20-mg GCC-4401C * Cohort 5: 40-mg GCC-4401C * Cohort 6: 80-mg GCC-4401C | Drug | Active |
| GCC-4401C* Capsule, identical in appearance to GCC-4401C, for oral use * single dose * dosage * Cohort 1: 2.5-mg matching placebo * Cohort 2: 5.0-mg matching placebo * Cohort 3: 10-mg matching placebo * Cohort 4: 20-mg matching placebo * Cohort 5: 40-mg matching placebo * Cohort 6: 80-mg matching placebo | Drug | Placebo |
Primary outcome
The number and percentage of subjects experiencing 1 or more AEs will be summarized by treatment/dose group, relationship to study drug, and severity.
Time frame: up to 7 ~ 10 days after administraion
Statistics for clinical laboratory data(continuous variables only), vital signs, and ECF intervals will be presented for each evaluation during the study and for change from baseline to postdose evaluations.
Time frame: up to 7 ~10 days after administration
1 secondary outcome
the single-dose pharmacokinetic behavior
Time frame: at predose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, and 48 hours postdose
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 29 Aug 2012.
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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 GCC-4401 and GCC-4401C in people with Healthy Male, 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 7 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 29 Aug 2012. 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 number and percentage of subjects experiencing 1 or more AEs will be summarized by treatment/dose group, relationship to study drug, and severity. (time frame: up to 7 ~ 10 days after administraion). The study lists 2 primary outcomes in all. 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 29 Aug 2012.