Study to Evaluate the PK, Relative Bioavailability and Safety of TG-2349 With Single Oral Dose Under Fed Condition in Healthy Volunteers

NCT02108418 | Completed Phase 1

• 1 other identifier: TG-2349-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To evaluate the safety and tolerability of TG-2349 in healthy volunteers.
3. 3.To evaluate the ethnic differences in PK and safety between East Asian and Caucasian volunteers.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Primary pharmacokinetic parameters: AUC0-t, AUC0-inf and Cmax

  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

  120 hours after administration of study drug in each session

• Urine pharmacokinetic parameters: Urine Ae%

  120 hours after administration of study drug in each session

• Stool pharmacokinetic parameters: Stool Ae%

  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.

  approximately 7 weeks

Study Arms (2)

TG-2349 as the original formulation

EXPERIMENTAL

400 mg, 2 syringes

Drug: TG-2349 as the original formulation

TG-2349 as a new capsule formulation

EXPERIMENTAL

400 mg, 4 capsules

Drug: TG-2349 as a new capsule formulation

Interventions

TG-2349 as the original formulation DRUG

single oral dose under fed condition

TG-2349 as the original formulation

TG-2349 as a new capsule formulation DRUG

single oral dose under fed condition

TG-2349 as a new capsule formulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• TaiGen Biotechnology Co., Ltd.: lead

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Nicole Sims, DO

  WCCT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 19, 2014

Record last verified: 2014-12

Locations

US (1)