Pharmacokinetics Clinical Trial
Official title:
A Single-Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of RHN-001 in Healthy Adult Volunteers.
Verified date | April 2023 |
Source | RH Nanopharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical Trial is to assess the safety, tolerability and Pharmacokinetic profile of 750 mg single oral dose of RHN-001 and 1500 mg of RHN-001 administered orally in fasted and fed conditions in healthy adult volunteers.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 19, 2023 |
Est. primary completion date | March 19, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Subject's written informed consent obtained prior to any study-related procedures. - Subject is a male/female with an age between 18 and 55 years of age, inclusive. - Subject has a body mass index between 18 and 32 kg/m2, inclusive. - Subject is judged to be in good health on the basis of medical history, complete physical examination, 12-lead electrocardiogram (ECG) and standard laboratory tests including complete hematology, blood chemistry, Lipid profile, Thyroid profile and urinalysis. - Subject understands the procedures and agrees to participate in the study program. Exclusion Criteria: - Subject is under the age of legal consent, or is mentally or legally incapacitated. - Subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering RHN-001 to the subject. - Subject has a recent history (10 years) of major cardiovascular, hepatic or renal disease. - Subject has liver function tests abnormalities with elevated AST or ALT greater than or equal to 2 times upper limit of normal and/or elevated bilirubin greater than or equal to 2 times upper limit of normal. - Subject has renal function tests abnormalities with serum creatinine greater than 1.8 g/dL. - Subject has any clinically significant abnormal hematological values in the opinion of the principal investigator. - Subject has abnormal serum concentrations of TSH, T3 or T4. - Subject has clinically significant abnormalities at physical examination, ECG or laboratory tests carried out at screening. - Subject has a history of psychiatric disorders, significant allergic conditions or known hypersensitivity to medications. - Subject is positive on testing for hepatitis B surface antigen, hepatitis C antibody or HIV 1 or 2 antibodies or tested positive for COVID-19 on rapid antigen testing. - Subject has donated blood within the 2 months before study drug administration. - Subject has a history of alcohol or drug abuse within the past year. - Subject used any over-the-counter drug during the 2 weeks prior to study drug administration (except occasional acetaminophen or vitamins). - Subject is positive on urine drug screening for drugs of abuse (cannabinoids, cocaine, opiates, amphetamines, barbiturates, benzodiazepines). - Subject tests positive for alcohol on Breath alcohol or urine screening. - Subject smokes more than 5 cigarettes per day. - Subject consumes caffeine more than 500 mg per day. - Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Center for Bioequivalence Studies and clinical research (CBSCR), ICCBS | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
RH Nanopharmaceuticals | Center for Bioequivalence Studies and Clinical Research |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability profile of SAD of RHN-001 | Number of subjects with adverse events (AEs) (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory parameters, weight, and physical examination. | up to 24 hours post dose in each cohort | |
Primary | Safety Endpoints of MAD of RHN-001 | Number of subjects with adverse events (AEs) (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead electrocardiogram (ECGs), clinical laboratory parameters, weight, and physical examination. | up to 24 hours post dose in each cohort | |
Secondary | maximum plasma concentration | maximum concentration of RHN-001 in plasma after dose in each cohort | up to 24 hours post dose | |
Secondary | Time to reach maximum plasma concentration | Time required for RHN-001 to reach maximum plasma concentration | up to 24 hours post dose | |
Secondary | AUC (Area under concentration vs time curve) | Area under the time versus plasma RHN-001 concentration curve | up to 24 hours post dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04092725 -
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04181008 -
Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers
|
Early Phase 1 | |
Active, not recruiting |
NCT03258151 -
Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
|
||
Completed |
NCT04406415 -
Oral Nafamostat in Healthy Volunteers
|
Phase 1 | |
Not yet recruiting |
NCT05421312 -
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
|
Phase 4 | |
Completed |
NCT02534753 -
A Pharmacokinetics Study of Intravenous Ascorbic Acid
|
Phase 1 | |
Completed |
NCT01636024 -
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
|
Phase 1 | |
Completed |
NCT01976078 -
Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents
|
N/A | |
Completed |
NCT01682408 -
Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability
|
Phase 1 | |
Completed |
NCT01208155 -
Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets
|
Phase 1 | |
Completed |
NCT01214941 -
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
|
Phase 4 | |
Completed |
NCT01415102 -
A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
|
Phase 1 | |
Completed |
NCT01260025 -
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
|
Phase 1 | |
Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
Completed |
NCT00746499 -
Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.
|
Phase 1 | |
Completed |
NCT00984009 -
A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice
|
Phase 1 | |
Completed |
NCT00856570 -
A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects
|
Phase 1 | |
Completed |
NCT00983242 -
Drug-Drug Interaction Between Colchicine and Verapamil ER
|
Phase 1 | |
Completed |
NCT01055964 -
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
|
Phase 3 | |
Completed |
NCT00730145 -
A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
|
Phase 1 |