Clinical trials: Pharmacokinetics
Postoperative Pain Management in Total Knee Arthroplasty
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management in total knee…
- Trial name
- NCT06509958
- Testing
- HR18034, Ropivacaine Hydrochloride Injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Advanced Solid Tumor
Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors
ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal…
- Trial name
- NCT07408258
- Testing
- ONC-783
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- OncoC4, Inc.
Pharmacokinetics of Vepoloxamer, Healthy Volunteers
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.
- Conditions
- Pharmacokinetics of Vepoloxamer, Healthy Volunteers, Renal Impaired
- Trial name
- NCT02646358
- Testing
- Vepoloxamer
- Where
- 2 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mast Therapeutics, Inc.
Solid Tumors Harboring a TP53 Y220C Mutation
A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation
The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation
- Trial name
- NCT06908434
- Testing
- GenSci128 tablets
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Hemophilia
A Phase I Safety, Pharmacokinetics and Pharmacodynamics Study of Recombinant Factor VIIa in Adult Patients With Hemophilia A or B
This study will assess the pharmacokinetics and pharmacodynamics of rhFVIIa at three dose levels. The results will help identify the most optimal doses to take forward to the Phase 2/3 studies where bleedings in hemophilia…
- Trial name
- rhFVIIa (NCT01708564)
- Testing
- rhFVIIa
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 15 people
- Sponsor
- rEVO Biologics
Healthy Volunteer, Pharmacokinetic Study
A Study of Ralinepag in Healthy Chinese Adult Subjects
A Phase 1 Open-label, Non-randomized, Single Ascending Dose Escalation Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of A Ralinepag Extended Release (XR) Tablet Formulation In Healthy Chinese Subjects.
- Trial name
- NCT04613999
- Testing
- Ralinepag
- Where
- China
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Everstar Medicines (Shanghai) Limited
Alzheimer Disease
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy Japanese young male and elderly subjects.To provide the pharmacokinetics (PK) and pharmacodynamics (PD)…
- Trial name
- NCT00479349
- Testing
- SAM-531
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Human Immunodeficiency Virus, HIV
Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of an islatravir (ISL)-eluting implant.
- Trial name
- NCT05115838
- Testing
- Islatravir
- Volunteers
- healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Acute Pain
Pharmacokinetics and Safety of MNK-155 in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain
An open-label study of the pharmacokinetics (PK) and safety of MNK-155 in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain.
- Trial name
- NCT02767349
- Testing
- MNK-155
- Where
- United States
- Sponsor
- Mallinckrodt
Osteoarthritis, Knee
Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis
The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee.
- Trial name
- STEPUP (NCT02609126)
- Testing
- EP-104IAR, Vehicle
- Where
- 3 sites in Canada
- Volunteers
- 32 people
- Sponsor
- Eupraxia Pharmaceuticals Inc.
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes
A Study to Learn How Safe the Study Treatment Elinzanetant is and How it Moves Into, Through and Out of the Body When Given as Single Increasing Doses That Are Higher Than Normally Used Compared to Placebo and Moxifloxacin in Healthy Participants
Researchers are looking for a better way to treat vasomotor symptoms, a condition of having hot flashes. The condition is caused by hormonal changes and occurs primarily in women, but can also affect men.
- Conditions
- Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men, Hot Flashes, Healthy Volunteers
- Trial name
- NCT05481528
- Testing
- Moxifloxacin, Elinzanetant (BAY3427080)
- Where
- Germany
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Bayer
Pulmonary Arterial Hypertension
Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation Solution
This is a randomised, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, and PK of single and multiple inhaled doses of imatinib inhalation solution (AER-901) in healthy adult…
- Trial name
- NCT04903730
- Testing
- AER-901 Solution for Nebulization
- Where
- Australia
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Aerami Therapeutics
Solid Tumors
A Study to Evaluate the Safety and Tolerability of RO7296682 in Combination With Atezolizumab in Participants With Advanced Solid Tumors.
This study will evaluate the safety, tolerability and preliminary anti-tumor activity of RO7296682 in combination with Atezolizumab in participants with advanced solid tumors.
- Trial name
- NCT04642365
- Testing
- RO7296682, Atezolizumab
- Where
- 10 sites in United States, Australia and 4 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Congenital Bleeding Disorder, Haemophilia A
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who…
- Trial name
- pathfinder™5 (NCT01731600)
- Testing
- turoctocog alfa pegol
- Where
- 51 sites in United States, Brazil and 14 more
- Volunteers
- 68 people
- Sponsor
- Novo Nordisk A/S
Healthy
A Study To Estimate The Effect of PF-06650833 On The Pharmacokinetics (PK) of Oral Contraceptive (OC)
This is a Phase 1, open label, fixed sequence study of the effect of multiple dose PF-06650833 on single dose OC PK in healthy female subjects.
- Trial name
- NCT05064332
- Testing
- PF-06650833, Ethinyl estradiol (EE) and levonogestrel (LN)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes
Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847 following administration of multiple rising oral doses over 8 days in patients with type 2 diabetes.
- Trial name
- NCT02211963
- Testing
- BI 44847
- Volunteers
- 48 people
- Sponsor
- Boehringer Ingelheim
Schizophrenia, Schizoaffective Disorder
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Central Nervous System Diseases
- Trial name
- NCT01556763
- Testing
- EVP-6124 (0.3 mg/day), EVP-6124 (1.0 mg/day), Antipsychotic therapy
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- FORUM Pharmaceuticals Inc
Breast Cancer
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers
This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male…
- Trial name
- NCT05738993
- Testing
- BCD-178, Perjeta
- Where
- 2 sites in Russia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Biocad
Osteoarthritis, Knee, Osteoarthritis, Hip
To Assess the Patients' Ability to Self-Administer Fasinumab
The primary objective is to demonstrate that the auto-injector(AI) is suitable to be used to administer fasinumab at home by patients or their caregivers, as measured by collecting 12 weeks of actual-use data on the technical…
- Trial name
- FACT DEVICE (NCT03491904)
- Testing
- Fasinumab AI, Fasinumab PFS
- Where
- 23 sites in United States
- Volunteers
- 100 people
- Sponsor
- Regeneron Pharmaceuticals
Advanced Solid Tumors
Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-706 as a monotherapy…
- Trial name
- NCT05599984
- Testing
- ABBV-706, Cisplatin, Budigalimab
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 288 people
- Sponsor
- AbbVie
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