Clinical trials: Evaluate PK Profile
Venous Thromboembolism
Pharmacokinetic (PK) Assessment of BIBR 1048 in Patients After Primary Elective Total Hip Replacement Surgery
To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.
- Trial name
- NCT02170935
- Testing
- BIBR 1048 capsule
- Volunteers
- 62 people
- Sponsor
- Boehringer Ingelheim
Infection, Bacterial, Antibiotic Side Effect
Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Getting the right dose of antibiotic promptly is an important part of treating infections. Unfortunately, when an infection is severe (sepsis) the body changes how it processes antibiotics.
- Conditions
- Infection, Bacterial, Antibiotic Side Effect, Antibiotic Resistant Infection, Sepsis
- Trial name
- MD-PK (NCT05950984)
- Testing
- Drug Infusion Pump Monitoring
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- St George's, University of London
Renal Impairment
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
PK and safety profile of Proellex® in females with various stages of impaired renal function
- Trial name
- NCT00787618
- Testing
- 50 mg Proellex
- Where
- 4 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Healthy Volunteers
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects
- Trial name
- NCT03279146
- Testing
- Tenofovir exalidex (TXL)
- Where
- United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- ContraVir Pharmaceuticals, Inc.
Bronchiolitis
Safety and Pk Study in 1- to 3- Month-Old Children With Bronchiolitis (0476-297)
The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 1 to < 3 months of age with bronchiolitis.
- Trial name
- NCT00394160
- Testing
- MK0476, Montelukast Sodium /Duration of Treatment : 14 Days
- Volunteers
- 12 people
- Sponsor
- Organon and Co
Hemophilia a and B
KN057 Multiple Dose Study in Patients with Hemophilia a or Hemophilia B with or Without Inhibitors
The goal of this clinical trial is to evaluate the safety and efficacy of KN057 in adult patients with severe Hemophilia A (coagulation factor FVIII activity <1%) or moderate-to-severe Hemophilia B (FIX activity ≤2%).
- Trial name
- NCT06747416
- Testing
- KN057
- Volunteers
- 24 people
- Sponsor
- Suzhou Alphamab Co., Ltd.
Alzheimer's Disease
Relative Bioavailability Study in Healthy Subjects to Evaluate the Pharmacokinetics of HTL0009936 After One Dose of Prototype Formulation
The purpose of this study is to find a modified release oral tablet formulation for this drug, which will be safe and well tolerated.
- Trial name
- NCT02710188
- Testing
- HTL0009936 modified release, HTL0009936 immediate release
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Drug Toxicity
MW151-101: First-in-human Study of MW151
MW01-2-151SRM (=MW151), a small molecule, is being developed for the treatment of cognitive disorders. The development program is based on nonclinical evidence that MW151 improves neurocognitive outcomes in animal models of…
- Trial name
- NCT04120233
- Testing
- MW151, 10mg, MW151, 20mg, MW151, 40mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Linda Van Eldik
Healthy, Multiple Sclerosis
Peginterferon Beta-1a (BIIB017) Autoinjector Pharmacokinetic Study in Healthy Volunteers
The purpose of this study is to characterize the pharmacokinetic (PK) profile, safety, and tolerability of peginterferon beta-1a (BIIB017) delivered by the single-use autoinjector or prefilled syringe (PFS) in healthy volunteers…
- Trial name
- NCT01610310
- Testing
- BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS), BIIB017 (peginterferon beta-1a) Autoinjector
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Biogen
Growth Hormone Deficiency
Safety, Tolerability and PK/PD Study in Young Adult Patients With Childhood Onset Growth Hormone Deficiency (GHD).
Study to find the optimal dose of Growth Hormone Replacement in young adult patients suffering from childhood onset growth hormone deficiency (GHD).
- Trial name
- NCT00778518
- Testing
- ARX201
- Where
- Hungary
- Volunteers
- 36 people
- Sponsor
- Ambrx, Inc.
Hepatic Cirrhosis, Alcoholism
Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
- Trial name
- NCT00698464
- Testing
- Pasireotide
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
Parkinson's Disease
Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's Disease
This study will be conducted in subjects with established Parkinson's disease in 2 parts. Part A will examine the tolerability, safety, and pharmacokinetics of AZ-009 dose escalation ; and Part B will assess the tolerability…
- Trial name
- NCT04157933
- Testing
- 009-A1, 009-A2, 009-A3
- Where
- Netherlands
- Volunteers
- 35 people
- Sponsor
- Alexza Pharmaceuticals, Inc.
Gram Positive Infection, Concurrent Antibiotic Treatment
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a…
- Trial name
- NCT00679835
- Testing
- daptomycin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Pneumonia
PK Analysis of Moxifloxacin in the Treatment of CAP
At the Department of Infectious Diseases, Aarhus Denmark, moxifloxacin is used in the empirical treatment of severe community-acquired pneumonia (CAP).
- Trial name
- NCT01983839
- Where
- Denmark
- Volunteers
- 18 people
- Sponsor
- University of Aarhus
Healthy
Comparative PK, Safety, Tolerability, Immunogenicity, and PD Profile Study of TUR03 and Soliris in Healthy Participants
This study is designed as a randomized, double-blind, parallel-group study to evaluate the PK, safety, tolerability, immunogenicity, and PD of TUR03 compared to Soliris, when administered as a single IV infusion in healthy adult…
- Trial name
- NCT05863442
- Testing
- Soliris 300 MG in 30 ML Injection, TUR03 300 MG in 30 ML Injection
- Where
- Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Turgut Ardika PTY LTD
Tuberculosis, Tuberculosis, Pulmonary
Study to Evaluate Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
A Phase 1, Partially-Blinded, Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Include A Single Dose Food-Effect Study to Evaluate the Safety, Tolerability, and the PK Profile of TBI-223 in Healthy Subjects
- Trial name
- NCT04865536
- Testing
- TBI-223 1800 mg, TBI-223 2400mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Global Alliance for TB Drug Development
Adult Growth Hormone Deficiency
Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
This is a multiple-dose, dose-escalation, randomized, double-blind, placebo-controlled phase Ⅱa clinical trial. A total of 36 adult participants with growth hormone deficiency will be enrolled sequentially in ascending dose…
- Trial name
- NCT07551804
- Testing
- Inpegsomatropin Injection
- Where
- 6 sites in China
- Volunteers
- 36 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Cystic Fibrosis
An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects
Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.
- Trial name
- NCT03424252
- Testing
- FDL169
- Where
- United Kingdom
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Flatley Discovery Lab LLC
Hereditary Angioedema
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
This is a 3 part, phase 1 crossover study in healthy subjects to evaluate the pharmacokinetic profile of KVD824 following single and multiple doses of novel KVD824 modified-release formulations compared with a reference KVD824…
- Trial name
- NCT05118958
- Testing
- KVD824 Prototype 1 modified-release tablet, KVD824 Prototype 2 modified-release tablet, KVD824 Immediate-Release Capsule
- Where
- United Kingdom
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Non-small Cell Lung Cancer, Melanoma
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® in Multiple Resected Solid Tumors
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety, and immunogenicity of HLX17 vs.
- Conditions
- Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma
- Trial name
- NCT07160335
- Testing
- HLX17, US-sourced Keytruda®
- Where
- 69 sites in United States, China and 2 more
- Volunteers
- 174 people
- Sponsor
- Shanghai Henlius Biotech