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About
This single-dose, open-label, randomized, four-way crossover study evaluates the pharmacokinetics, safety, and tolerability of TAH3311 5 mg in healthy volunteers under fasted and fed conditions.
Full description
Eligible subjects will be enrolled in the study across four sequences (anticipate 15 subjects per sequence). This study will have three phases: Screening Phase, Treatment Phase, and Follow-Up Phase. Subjects will be randomized 1:1:1:1 to receive TAH3311 ODF 5 mg under fasted (T1) and fed conditions (T2) and ELIQUIS® 5 mg (US RS/RLD [R1] and EU product [R2]) under fasted condition via one of the four sequences with serial PK sampling from 90 minutes pre-dose to 48 hours post-dose. The duration of each treatment period is 4 days, with a 7±2 days washout in between of the treatment administration. The follow-up period will be 7±3 days after the last treatment dosing.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
Exclusion criteria
Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment:
The subject has a history of severe allergic or anaphylactic reactions.
The subject has a known allergy or hypersensitivity 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.
The subject has a medical history or current evidence of system disorders, organ dysfunction especially cardiovascular disorders (e.g., atrial fibrillation), renal or hepatic disorders which in the opinion of the Investigator, would compromise the safety of the subject or the study.
Female subjects who are pregnant or lactating.
The subject has a Family history of sudden cardiac death.
The subject has a history of blood clots or bleeding disorders (e.g., bleeding diathesis [tendency to bleed or bruise easily]), stroke, or active pathological bleeding.
The subject has a 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.
The 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.
The subject has a positive test for human immunodeficiency virus (HIV) types 1 or 2, Hepatitis B surface antigen or Hepatitis C antibody (HCV) at screening.
Subject has any active infection requiring systemic therapy at the time of screening, which is considered clinically significant per the Principial Investigator.
The investigator determined the subject has a history of or ongoing chronic or recurrent infectious disease (e.g., infected indwelling prosthesis, osteomyelitis, chronic sinusitis)
Drug or alcohol addiction requiring treatment in the 12 months before initial dosing.
History of excessive alcohol consumption (on average more than 14 units of alcohol/week; 1 unit = 12 oz. beer, 6 oz. wine, 1 shot [1.5 oz.] of liquor) during the past 12 months.
The subject has taken any medications (including herbal remedies) known to significantly induce or inhibit drug metabolizing enzymes (especially inhibitors and inducers of CYP3A4 and P-gp such as ketoconazole, itraconazole, ritonavir, clarithromycin, rifampin, phenytoin, carbamazepine, St. John's Wort, etc.) within 30 days before initial dosing and other medications deemed acceptable by the Principal Investigator.
Clinically significant history or presence of gastrointestinal disease (e.g., bleeding, perforation, or fistulas) or malabsorption, as determined by the Investigator.
The subject has participated in another clinical study of a new investigational drug or has received an investigational drug within 28 days or 5 half-lives (if available) before study drug administration, whichever is longer.
Anticipating undergoing surgery or medical/dental procedure, receiving neuraxial anesthesia (spinal/epidural anesthesia), or undergoing spinal puncture during the study or within 7 days after study completion.
Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days before initial dosing.
Subject has difficulty swallowing, as determined by the investigator.
Subject has a prosthetic heart valve.
Subject has abnormal prothrombin time (PT) and activated partial thromboplastin time (aPTT).
The subject has serum creatinine ≥1.5 mg/dL
eGFR<90 mL/min/1.73 m2; obtained from the clinical laboratory tests performed at screening.
Use of drugs affecting hemostasis such as aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and nonsteroidal anti-inflammatory drugs (NSAIDs) within 14 days before initial dosing.
Positive test results for drugs of abuse or cotinine at screening
The subject is unable to participate in, or successfully complete, the study, in the opinion of the investigator, because the subject is any of the following:
Primary purpose
Allocation
Interventional model
Masking
60 participants in 4 patient groups
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Central trial contact
Aishia T Henderson
Data sourced from clinicaltrials.gov
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