Comparative Bioavailability Study of TAH3311 5 mg Oral Dissolving Film vs ELIQUIS® 5 mg Tablet in Healthy Volunteers

NCT05995119 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: TAH3311-12288201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the pharmacokinetic profiles and bioequivalence, and to determine the safety and tolerability of the TAH3311 Oral Dissolving Film (ODF) 5mg compared with ELIQUIS® (Apixaban) 5mg Oral Tablet, after single dose under fasted and fed conditions in healthy volunteers.

Conditions

Healthy Volunteers; Fasting; Fed

Outcome Measures

Primary Outcomes (3)

• Plasma Concentration (Cmax) of Apixaban under fasted condition

  0, 0.33, 0.67, 1.0, 1.5, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0 hours post dose

• Area under the plasma concentration curve from time zero to last sampling time (AUC0-t) of Apixaban under fasted condition

  0, 0.33, 0.67, 1.0, 1.5, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0 hours post dose

• Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of Apixaban under fasted condition

  0, 0.33, 0.67, 1.0, 1.5, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0 hours post dose

Study Arms (2)

Comparative Bioavailability of apixaban film (TAH3311) and Eliquis Tablet in fed conditions

OTHER

Drug: Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®)

Comparative Bioavailability of apixaban film (TAH3311) and Eliquis Tablet in fast conditions

OTHER

Drug: Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®)

Interventions

Apixaban 5 mg Oral Dissolving Film (TAH3311) and Tablet (Eliquis®) DRUG

The subjects were administered either the test (TAH3311 5 mg ODF as Treatment T1) or reference (ELIQUIS® 5 mg oral tablet as Treatment R1) product at 30 minutes following the start of a standardized high-fat, high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. In the other two study periods, the subjects were administered either the test (Treatment T2) or reference (Treatment R2) product following an overnight fast of at least 10 hours. The subjects received the test and reference products in accordance with a four-sequence randomization schedule. There was a washout period of 5 days between the dosing days of any two consecutive periods.

Also known as: TAH3311 5 mg ODF

Comparative Bioavailability of apixaban film (TAH3311) and Eliquis Tablet in fast conditions; Comparative Bioavailability of apixaban film (TAH3311) and Eliquis Tablet in fed conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-lactating females, 18-80 years of age, inclusive.
• A minimum body weight of 60 kg and a Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
• Female subjects must meet at least one of the following requirements:
• Agree to abstain from sexual intercourse from screening and throughout the duration of the study, including washout periods, and for 30 days after the last study drug administration.
• Have used and agree to continue to use a reliable method of hormonal contraception (oral, implanted, or injected) in conjunction with a barrier method (e.g., diaphragm, cervical cap, male condom, and female condom and spermicidal foam, sponges, and film) for at least 30 days before initial dosing and throughout the duration of the study, including washout periods, and for 30 days after the last study drug administration.
• Have used and agree to continue to use an intrauterine device (IUD) at least 3 months before initial dosing and throughout the duration of the study, including washout periods, and for 30 days after the last study drug administration.
• Surgically sterile (bilateral oophorectomy or hysterectomy, bilateral tubal ligation at least 3 months before initial dosing or Essure® device placement before the year 2018).
• At least 2 years postmenopausal and have a documented follicle stimulating hormone (FSH) level ≥ 40 milli-international units per milliliter (mIU/mL) at screening.
• Male subjects who are not surgically sterile must agree to abstain from sexual intercourse (complete abstinence) or use appropriate contraceptive measures and agree to not impregnate a female partner(s) and not to donate sperm throughout the entire study, including the washout periods, and for 30 days after the last study drug administration. Examples of acceptable methods of contraception include a double-barrier method of contraception (e.g., condom with spermicide). Other forms of contraception may be acceptable, at the discretion of the Investigator.
• Subject is judged by an Investigator to be in good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Any abnormalities or deviations outside the normal ranges for any clinical testing (e.g., laboratory tests, ECG, vital signs) may be repeated, at the discretion of the Investigator(s), and judged by an Investigator to be not clinically significant for study participation.
• Subject doesn't have any relevant dietary restrictions, as determined by the Investigator, and is willing to consume a high-fat, high-calorie breakfast and other standard meals provided during the treatment periods of the study, and to comply with the fasting conditions required by the study design.
• Subject is able to read and speak English fluently. Subjects will be required to read, understand, sign and date the informed consent form, which meets all criteria of current FDA regulations, and must be able to understand the information and instruction given to them during the study.

You may not qualify if:

• Females who are pregnant, lactating, or likely to become pregnant during the study.
• History of allergy or sensitivity to apixaban, or history of any food or drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
• Current tongue piercing or other piercings in the mouth, including lips and cheeks which have studs/rings, etc. or where the piercing wound is not completely closed or any tongue or other oral deformities that may affect the absorption of the drug product.
• Significant history or current evidence of system disorders, organ dysfunction especially cardiovascular disorders (e.g., atrial fibrillation), renal or hepatic disorders.
• Significant familial history of sudden cardiac death, as determined by the Investigator.
• Subject has a prosthetic heart valve.
• Significant history or current evidence of blood clots or bleeding disorders (e.g., bleeding diathesis \[tendency to bleed or bruise easily\]), stroke, or active pathological bleeding.
• Clinically significant history or are currently at risk for arterial or venous thromboembolic events (e.g., transient ischemic attack, cerebrovascular accident, myocardial infarction, retinal artery occlusion or retinal vein thrombosis, pulmonary embolism, deep vein thrombosis, antiphospholipid syndrome), as determined by the Investigator.
• Serum creatinine ≥ 1.5 mg/dL.
• Creatinine clearance (CrCl) \< 50 mL/min; obtained from the clinical laboratory tests performed at screening. CrCl can be estimated using the following (Cockcroft-Gault) equation:
• CrCl= ((140-age) × actual weight(kg) × \[0.85 if female\])/(SerumCr(mg⁄dL) × 72)
• Clinically significant history or presence of gastrointestinal disease (e.g., bleeding, perforation, or fistulas) or malabsorption, as determined by the Investigator.
• Subject has had an acute infection within 2 weeks before screening or at any time between screening and check-in including, but not limited to, history, signs, or symptoms of a common cold (e.g., mild rhinorrhea), untreated oral/dental abnormalities (e.g., untreated dental caries as determined by examination of the mouth), or untreated disruption of the skin, as determined by the Investigator.
• Subject has an active infection requiring systemic therapy at the time of screening, which is considered clinically significant by the Investigator.
• Subject has a significant history of or ongoing chronic or recurrent infectious disease (e.g., infected indwelling prosthesis, osteomyelitis, chronic sinusitis), as determined by the Investigator.

Sponsors & Collaborators

• TAHO Pharmaceuticals Ltd.: lead

Study Sites (1)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Conditions

Fasting; Lecithin Cholesterol Acyltransferase Deficiency

Interventions

apixaban; Tablets

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Hypoalphalipoproteinemias; Hypolipoproteinemias; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Philip Mathew, M.D.

  Novum Pharmaceutical Research Services, USA

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 16, 2023
• Study Start: December 5, 2022
• Primary Completion: December 28, 2022
• Study Completion: January 13, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

US (1)