A Phase 1, Open-Label, 2-Period, 2-Formulation, Within-Subject Crossover Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose Level of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Human Subjects Under Fasting Conditions

Rhoshan Pharmaceuticals Inc1 site in 1 country24 target enrollmentDecember 3, 2021

ConditionsHealthy

InterventionsRho-11 aspirin 325mg

DrugsRho-11 aspirin 325mg

Overview

Phase: Phase 1
Intervention: Rho-11
Conditions: Healthy
Sponsor: Rhoshan Pharmaceuticals Inc
Enrollment: 24
Locations: 1
Primary Endpoint: Change in serum thromboxane B2 from baseline
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.

Registry

clinicaltrials.gov

Start Date

December 3, 2021

End Date

May 11, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Rhoshan Pharmaceuticals Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Each subject must meet all of the following criteria to be enrolled in this study:
•The subject is male or female 18 to 55 years of age, inclusive
•The subjects has a body mass index (BMI) 18 to 30 kg/m2, inclusive, at screening.
•The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
•The subject has a hemoglobin level within following acceptable range at Screening and Check-in: Male: 12.8 to 17.4 g/dL, Female: 10.8 to 15.0 g/dL
•The subject has liver function tests within normal limits, or has results that do not show clinically significant abnormalities, as judged by the investigator at Screening and Check in.
•The subject has estimated glomerular filtration rate (eGFR) ≥ 50 mL/min at Screening.
•Female subjects of childbearing potential must use an acceptable method of birth control (i.e., diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide, oral contraceptives, or abstinence) or be surgically sterile (i.e., hysterectomy, bilateral tubal ligation or bilateral oophorectomy), or postmenopausal (defined as amenorrhea 12 consecutive months and documented plasma FSH level \>40 IU/mL). Female subjects must have a negative pregnancy test at screening and before dosing with study drug.
•Male subjects with female partners of childbearing potential must be vasectomized, be willing to use an acceptable method of birth control, or to practice abstinence during the study.
•The subject agrees to comply with all protocol requirements.

Exclusion Criteria

•Subjects meeting any of the following criteria will be excluded from the study:
•The subjects has had any major illness within 3 months before dosing with study drug or any significant ongoing chronic medical illness, as judged by the investigator.
•The subjects has a history of active deep vein thrombosis and/or thromboembolic disorder, including history of hypothrombinemia and vitamin K deficiency.
•The subject has a history of neuropsychiatric disease, hypertension, cardiac failure, cerebrovascular disease, chronic respiratory disease, asthma, nasal polyps associated with asthma, hepatic or renal impairment, recent dehydration (within last 30 days), gout thyrotoxicosis or systemic lupus erythematosus and other connective tissue disorders.
•The subject has a history of gastrointestinal bleeding or has active gastrointestinal disease that could affect drug absorption.
•The subject has a history of hemorrhagic disorder.
•Prothrombin time or activated partial thromboplastin time level outside the normal range at screening and check-in.
•The subject has an increased risk of bleeding including but not limited to: any history of a clinically significant bleeding problem, any recent (within 30 days preceding the first dose of study drug) major trauma, platelet count \<100,000 mm3
•The subject has a history of glucose-6-phosphate dehydrogenase deficiency.
•The subject has a recent history of tooth extraction within 3 weeks before dosing with study drug.

Arms & Interventions

Rho-11 administered in Period 1, oral aspirin administered in Period 2

Intervention: Rho-11

Rho-11 administered in Period 1, oral aspirin administered in Period 2

Intervention: aspirin 325mg

Oral aspirin administered in Period 1, Rho-11 administered in Period 2

Intervention: Rho-11

Oral aspirin administered in Period 1, Rho-11 administered in Period 2

Intervention: aspirin 325mg

Outcomes

Primary Outcomes

Change in serum thromboxane B2 from baseline

Time Frame: 1 hour before dosing and 2, 5, 10, 20, 30,45, 60, and 180 minutes post dosing

Change in serum thromboxane B2 from baseline to 180 minutes post treatment

Secondary Outcomes

Urinary 11-dehydro-TXB2 levels(Every 12 hours from 72 hours prior to dosing to 72 hours after dosing.)
Urinary 2,3-dinor-6-keto-PGF1alpha(Every 12 hours from 72 hours prior to dosing to 72 hours after dosing.)
Acetylsalicylic Acid Plasma Pharmacokinetics(1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.)
Salicylic Acid Plasma Pharmacokinetics(1 hour prior to dosing, and 1,3,5,10,15,20,30, and 45 minutes and 1,1.5,2,3,6,8, and 24 hours post-dosing.)