HealthyPhase 1NCT02108418
Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers
A Phase 1 study testing TG-2349 as the original formulation and TG-2349 as a new capsule formulation in people with Healthy, run by TaiGen Biotechnology Co., Ltd. at 1 site in United States.
Trial summary
1. To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers. 2. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- TG-2349 as the original formulation and TG-2349 as a new capsule formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- East Asian or Caucasian subjects, male or female, and 18 to 40 years of age inclusive
- Body mass index (BMI) in the range of 19.0 to 30.0 kg/m2 and body weight ≥ 50 kg inclusive
- In general good physical and mental health status on the basis of a medical history review, medical evaluation including vital signs and physical examination, 12-lead ECG, and laboratory results at screening
- For females, one of the following criteria must be fulfilled:
- (1)At least 1 year post menopausal, or (2)Surgically sterile, or (3)Willing to use a double-barrier method (intrauterine device [IUD] plus condom, spermicidal gel plus condom) of contraception from screening until 30 days after the last dose of study drug; 5.Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from screening until 30 days after the last dose of study drug 6.Willing to abstain from caffeine- or xanthine-containing beverages (including coffee and tea), alcohol, grapefruit juice, and Seville oranges during the stay-on-site period 7.Willing and able to provide written informed consent
Who cannot join
- Positive serological test for IgM anti-HAV antibody, HbsAg, or anti-HCV antibody at screening
- Positive ELISA test for HIV-1 or HIV-2 at screening
- Any of the following abnormal laboratory values at screening: Hemoglobin (Hb) <12.0g/dL for women and <13.0g/dL for men, white blood cell count (WBC) <3,000 cells/mm3, absolute neutrophil count <1,500 cells/mm3, platelet count <100,000 cells/mm3, serum creatinine ≥ 2 mg/dL, ALT or AST levels ≥ 2 xULN, total bilirubin ≥ 1.5 xULN, INR (International Normalized Ratios for prothrombin time) ≥1.5 xULN
- Any abnormal laboratory values that are considered clinically significant by the Investigator at screening
- QTcF greater than 450 msec for females and 430 msec for males at screening
- History of renal, hepatic impairment, stomach or intestinal surgery or resection, malabsorption syndrome
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- History of seizures, epilepsy, cardiovascular, diabetes, or cancer (except basal cell carcinoma)
- History or family history of prolonged QT interval or family history of sudden cardiac death at a young age (< 30 years )
- History of drug allergy or hypersensitivity, especially to sulfa drugs
- History or evidence of abuse of alcohol, barbiturate, amphetamine, recreational, or narcotic drug use within 6 months prior to first dose of study drug administration
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of a psychiatric illness, or who have any history of suicide attempt or depression
- Anemia or blood/plasma donation within 30 days prior to first dose of study drug administration
- Pregnant or breast-feeding
- Use of tobacco or nicotine-containing products within 30 days prior to first dose of study drug administration
- Use of concomitant medication, including herbal remedies and dietary supplements (except for paracetamol/acetaminophen, ibuprofen, and hormonal contraceptives) within 14 days prior to first dose of study drug administration
- Received any other investigational drug within 30 days prior to first dose of study drug administration
- Any of the following abnormal laboratory values at admission: Hb <12.0g/dL for women and <13.0g/dL for men, WBC <3,000 cells/mm3, absolute neutrophil count <1,500 cells/mm3, platelet count <100,000 cells/mm3, serum creatinine ≥ 2 mg/dL, ALT or AST levels ≥ 2 xULN, total bilirubin ≥ 1.5 xULN, INR ≥ 1.5 xULN
- Any abnormal laboratory values that are considered clinically significant by the Investigator at admission
- Any clinically significant abnormality on 12-lead ECG or a QTcF greater than 450 msec for females and 430 msec for males at admission
- Positive urine drug screen or breath alcohol test at admission
- If female, positive serum pregnancy test at admission
- Acute illness within 2 weeks prior to dosing, unless approved by the Sponsor's Medical Monitor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, 2-way Crossover Study in Healthy East Asian and Caucasian Volunteers to Evaluate the Relative Bioavailability of A New Capsule Formulation of TG-2349 Compared to the Original Formulation of TG-2349 Oral Solution
- To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers.
- To evaluate the safety and tolerability of TG-2349 in healthy volunteers.
- To evaluate the ethnic differences in PK and safety between East Asian and Caucasian volunteers.
Read the detailed description
TG-2349 oral solution has been investigated in a phase I/IIa study (study number: TG-2349-01) in healthy volunteers and patients with chronic hepatitis C (CHC) infection. The study demonstrated that TG-2349 was safe and well-tolerated when given to healthy volunteers at single oral doses up to 800 mg, and at five-consecutive daily oral doses up to 600 mg. Co-administration of TG-2349 with food resulted in a significant increase in bioavailability, and therefore concomitant food intake with dosing is recommended.
To further advance the clinical development of TG-2349, a new capsule formulation was developed to replace the current TG-2349 oral solution. The objectives of this study (study number: TG-2349-02) are to evaluate the PK and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers, and to evaluate the safety, tolerability, and ethnic differences of the TG-2349 capsule formulation.
- Conditions
- Healthy
- Being tested
- TG-2349 as the original formulation, TG-2349 as a new capsule formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-2349 as the original formulationDrug
single oral dose under fed condition
TG-2349 as a new capsule formulationDrug
single oral dose under fed condition
| Study group | Role | What they receive |
|---|---|---|
| TG-2349 as the original formulation | Experimental | 400 mg, 2 syringes Receives: Drug: TG-2349 as the original formulation |
| TG-2349 as a new capsule formulation | Experimental | 400 mg, 4 capsules Receives: Drug: TG-2349 as a new capsule formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary pharmacokinetic parameters: AUC0-t, AUC0-inf and Cmax
Measured: 120 hours after administration of study drug in each session
Secondary outcomes (4)
Secondary pharmacokinetic parameters:Tmax, t1/2, CL/F, V/F and λz
Measured: 120 hours after administration of study drug in each session
Urine pharmacokinetic parameters: Urine Ae%
Measured: 120 hours after administration of study drug in each session
Stool pharmacokinetic parameters: Stool Ae%
Measured: 120 hours after administration of study drug in each session
Safety parameters: Incidence and severity of AEs, changes from baseline in safety laboratory values, 12-lead ECG parameters, vital signs, and physical examination.
Measured: approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Sims, DO, Principal investigator, WCCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108418
- Sponsor's protocol ID
- TG-2349-02
- Status last verified
- Dec 2014
- First submitted
- 27 Mar 2014
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, 2-way Crossover Study in Healthy East Asian and Caucasian Volunteers to Evaluate the Relative Bioavailability of A New Capsule Formulation of TG-2349 Compared to the Original Formulation of TG-2349 Oral Solution
- ClinicalTrials.gov ID
- NCT02108418
- Acronym / sponsor ID
- TG-2349-02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Apr 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.
- To evaluate the pharmacokinetics (PK) and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers.
- To evaluate the safety and tolerability of TG-2349 in healthy volunteers.
- To evaluate the ethnic differences in PK and safety between East Asian and Caucasian volunteers.
Detailed description
TG-2349 oral solution has been investigated in a phase I/IIa study (study number: TG-2349-01) in healthy volunteers and patients with chronic hepatitis C (CHC) infection. The study demonstrated that TG-2349 was safe and well-tolerated when given to healthy volunteers at single oral doses up to 800 mg, and at five-consecutive daily oral doses up to 600 mg. Co-administration of TG-2349 with food resulted in a significant increase in bioavailability, and therefore concomitant food intake with dosing is recommended.
To further advance the clinical development of TG-2349, a new capsule formulation was developed to replace the current TG-2349 oral solution. The objectives of this study (study number: TG-2349-02) are to evaluate the PK and relative bioavailability of TG-2349, given as a new capsule formulation and as the original formulation of oral solution, after a single oral dose of 400 mg under fed condition in healthy volunteers, and to evaluate the safety, tolerability, and ethnic differences of the TG-2349 capsule formulation.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TG-2349 as the original formulation | Experimental | Drug: TG-2349 as the original formulation400 mg, 2 syringes |
| TG-2349 as a new capsule formulation | Experimental | Drug: TG-2349 as a new capsule formulation400 mg, 4 capsules |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- East Asian or Caucasian subjects, male or female, and 18 to 40 years of age inclusive
- Body mass index (BMI) in the range of 19.0 to 30.0 kg/m2 and body weight ≥ 50 kg inclusive
- In general good physical and mental health status on the basis of a medical history review, medical evaluation including vital signs and physical examination, 12-lead ECG, and laboratory results at screening
- For females, one of the following criteria must be fulfilled:
- (1)At least 1 year post menopausal, or (2)Surgically sterile, or (3)Willing to use a double-barrier method (intrauterine device [IUD] plus condom, spermicidal gel plus condom) of contraception from screening until 30 days after the last dose of study drug; 5.Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from screening until 30 days after the last dose of study drug 6.Willing to abstain from caffeine- or xanthine-containing beverages (including coffee and tea), alcohol, grapefruit juice, and Seville oranges during the stay-on-site period 7.Willing and able to provide written informed consent
Key exclusion criteria (22 listed)
- Positive serological test for IgM anti-HAV antibody, HbsAg, or anti-HCV antibody at screening
- Positive ELISA test for HIV-1 or HIV-2 at screening
- Any of the following abnormal laboratory values at screening: Hemoglobin (Hb) <12.0g/dL for women and <13.0g/dL for men, white blood cell count (WBC) <3,000 cells/mm3, absolute neutrophil count <1,500 cells/mm3, platelet count <100,000 cells/mm3, serum creatinine ≥ 2 mg/dL, ALT or AST levels ≥ 2 xULN, total bilirubin ≥ 1.5 xULN, INR (International Normalized Ratios for prothrombin time) ≥1.5 xULN
- Any abnormal laboratory values that are considered clinically significant by the Investigator at screening
- QTcF greater than 450 msec for females and 430 msec for males at screening
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 |
|---|---|---|
| TG-2349 as the original formulationsingle oral dose under fed condition | Drug | TG-2349 as the original formulation |
| TG-2349 as a new capsule formulationsingle oral dose under fed condition | Drug | TG-2349 as a new capsule formulation |
Primary outcome
Primary pharmacokinetic parameters: AUC0-t, AUC0-inf and Cmax
Time frame: 120 hours after administration of study drug in each session
4 secondary outcomes
Secondary pharmacokinetic parameters:Tmax, t1/2, CL/F, V/F and λz
Time frame: 120 hours after administration of study drug in each session
Urine pharmacokinetic parameters: Urine Ae%
Time frame: 120 hours after administration of study drug in each session
Stool pharmacokinetic parameters: Stool Ae%
Time frame: 120 hours after administration of study drug in each session
Safety parameters: Incidence and severity of AEs, changes from baseline in safety laboratory values, 12-lead ECG parameters, vital signs, and physical examination.
Time frame: approximately 7 weeks
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 19 Dec 2014.
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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.
Nicole Sims, DO principal investigator
WCCT
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 TG-2349 as the original formulation and TG-2349 as a new capsule formulation in people with Healthy, run by TaiGen Biotechnology Co., Ltd. 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 22 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 19 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. 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?
Primary pharmacokinetic parameters: AUC0-t, AUC0-inf and Cmax (time frame: 120 hours after administration of study drug in each session). 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 19 Dec 2014.