Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects

NCT04352361 | Completed Phase 1

• 1 other identifier: 3V2640-CLIN-005-（I）-PK
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640 tablets in the Chinese healthy population.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Evaluation of the safety and tolerability of TVB-2640 in Chinese healthy volunteers: adverse events and serious adverse events

  Evaluation of number of patients reported with adverse events and serious adverse events.

  Up to 4 days

Secondary Outcomes (6)

• Evaluate the Cmax of TVB-2640

  Up to 3 days

• Tmax of TVB-2640

  Up to 3 days

• AUC of TVB-2640

  Up to 3 days

• t1/2 of TVB-2640

  Up to 3 days

• CL/F of TVB-2640

  Up to 3 days

Study Arms (2)

TVB-2640 tablets

EXPERIMENTAL

Drug: TVB-2640

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TVB-2640 DRUG

TVB-2640 tablets (25mg/50mg/75mg) one tablet at a time, once per day.

TVB-2640 tablets

Placebo DRUG

Oral, matching number of placebo Tablets with active arm.

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 50mg dose: half male and half female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 to 45 (including 18 and 45), both male and female(The 50mg dose half male and half female).
• Male weight ≥50 kg, female weight ≥45 kg; BMI between 19 and 24 kg/m2 (including boundary value).
• Those who have no family planning within half a year and are willing to take effective contraceptive measures within half a year after the last administration.
• Non-pregnant or lactating women.
• Voluntarily signing the informed consent.

You may not qualify if:

• Persons who have or are currently suffering from any serious clinical diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities or any other diseases (eye diseases such as corneal edema, keratitis, uveitis etc.) that can interfere with the test results.
• Previous corneal surgery, gastrointestinal surgery, vagus neurotomy, intestinal resection or any surgical operation that may interfere with gastrointestinal peristalsis, pH or absorption (except hernia repair, appendectomy).
• Persons with allergic constitution, including those with allergic history of drugs, food or other substances.
• Those who have used any prescription drugs, over-the-counter drugs, any vitamin products or herbs within 14 days prior to administration.
• Any drugs that inhibit or induce the liver to metabolize drugs (e.g., inducers - barbiturates, carbamazepine, phenytoin sodium, rifampicin) were used within 30 days prior to administration; Inhibitors - SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, pyrrole antifungal agents, HIV protease inhibitors, etc.), p-gp inducers (including rifampicin, st. John's wort, okazepine, and modafinil).
• Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the study.
• Alcoholics or regular drinkers in the 6 months prior to the trial, i.e., drinking more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine).
• Drinking excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups, 1 cup =250 mL) every day for 3 months before the first administration.
• Anyone who has consumed or plans to consume any food or beverage containing caffeine (such as coffee, strong tea, chocolate, etc.) or foods rich in xanthine (such as sardines, animal livers, etc.) or beverages within 48 hours prior to the first use of the study drug.
• Had consumed or planned to consume grapefruit or grapefruit-related citrus fruits (such as lime, grapefruit), star fruit, papaya, pomegranate or more fruit products within 3 days prior to administration.
• Patients who had donated blood or lost more than 400ml of blood within 3 months before administration.
• Patients who had participated in other clinical trials and received the study drug treatment within 3 months prior to the initial administration.
• Those who had used the first oral contraceptive pill within 30 days prior to the first administration, or those who had used long-acting estrogen or progesterone injections or implants within 6 months prior to the first administration.
• Those who had unprotected sex within 14 days before the first administration (female).
• Those who have special requirements on diet and cannot follow the unified diet.

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Hunan provincial people's hospital

Changsha, Hunan, 410002, China

Location

MeSH Terms

Interventions

TVB-2640

Study Officials

• Yahong Chen, MD

  Ascletis Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 20, 2020
• Study Start: April 2, 2020
• Primary Completion: April 29, 2020
• Study Completion: April 29, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-04

Locations

CN (1)