Clinical trials: Stage IV
Obesity
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
The main purpose of this study is measure the effect of VI-0521 on kidney function. Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of study treatment, and after an additional 4 weeks of…
- Trial name
- NCT02229214
- Testing
- Qsymia
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC
Healthy Volunteers, Renal Impairment
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
The purpose of this study is to characterize the effect of renal function on the plasma, urine, and dialysate pharmacokinetic profile of MK-6183 (CB-238,618) in humans.
- Trial name
- NCT02341599
- Testing
- MK-6183
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Disease, End Stage
PK Study of IV and Oral Amisulpride in Subjects With Severe Renal Impairment
The aim of the study is to understand how Amisulpride is taken up and distributed around the body and how quickly it is eliminated, when given by mouth and into a vein in adults with severe kidney disease.
- Trial name
- NCT04849650
- Testing
- Amisulpride IV, Amisulpride Oral Tablet
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Acacia Pharma Ltd
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Aspergillus Infections, Candida Infections
Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
- Conditions
- Aspergillus Infections, Candida Infections, Fungal Infections
- Trial name
- NCT02631954
- Testing
- Vorico Injection 200mg(Voriconazole), Vfend®(Voriconazole) IV 200mg
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Influenza, Human
A Study to Assess the Immunogenicity and Safety of CSL's 2012/2013 Formulation of Enzira® Vaccine in Healthy Volunteers
This is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of Enzira® (CSL Influenza vaccine) in healthy adult volunteers aged 18 years or older.
- Trial name
- NCT01591837
- Testing
- CSL Influenza Vaccine
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Seqirus
Marburg Virus Disease
A Study to Evaluate the Single Dose Safety, Tolerability and Pharmacokinetics of IV BCX4430
This is a placebo-controlled, randomized, double-blind study to evaluate the pharmacokinetics of galidesivir following administration of single doses by IV infusion
- Trial name
- NCT03800173
- Testing
- galidesivir
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Uterine Hemorrhage
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena.
- Trial name
- NCT01295294
- Testing
- Tranexamic acid, Mefenamic acid, Mirena (Levonorgestrel IUS, BAY86-5028)
- Where
- 12 sites in Denmark, Ireland and 1 more
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Bayer
GCP
Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations.
To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split…
- Trial name
- NCT06334510
- Testing
- One dose of quadrivalent influenza virus split vaccine was administered
- Where
- China
- Volunteers
- 4,900 people, healthy volunteers welcome
- Sponsor
- Hualan Biological Bacterin Co. Ltd.
Healthy Adult Subjects
Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX
This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
- Trial name
- NCT01366378
- Testing
- methylnaltrexone
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Encephalitis, Tick-Borne
Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults
The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults
- Trial name
- NCT00311493
- Testing
- Tick-Borne Encephalitis vaccine
- Where
- Germany
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Novartis
Arthritis, Rheumatoid
6-Month Phase I/II Open Label PRTX-100 in Previous Rheumatoid Arthritis Study Participants and Sera Collection
Part A Primary Objective To determine the safety of six months of PRTX-100 administration. Part B Primary Objective To obtain antisera from normal volunteers that have developed anti-PRTX-100 antibodies.
- Trial name
- SPARTA-II (NCT02330445)
- Testing
- PRTX-100
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Protalex, Inc.
Encephalitis, Tick-Borne
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children
The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.
- Trial name
- NCT00311441
- Testing
- Tick-Borne Encephalitis vaccine
- Where
- Germany
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Novartis
Smallpox
Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s (SF600s) generated during screening of service members for possible immunization with the ACAM2000® smallpox vaccine.
- Trial name
- NCT01540929
- Where
- United States
- Volunteers
- 5,001 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Healthy Volunteers
Phase 1 Bioavailability Study of MELT-100 (Midazolam and Ketamine Sublingual) and IV Midazolam or Ketamine
Comparative Bioavailability study testing MELT-100 (midazolam and ketamine sublingual tablet) and IV midazolam or ketamine in healthy volunteers
- Trial name
- NCT04485702
- Testing
- Midazolam injection, Ketamine Injectable Product, MELT-100
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Melt Pharmaceuticals
Pressure Ulcers Stage II, Pressure Ulcers Stage III
Comparison of Transforming Powder Dressing to NPIAP Recommended Standard of Care Therapies in Stage 2, 3 and 4 Pressure Injuries
Pressure injuries, commonly known as pressure ulcers, affect over 2.5 million people in the United States. Pressure injuries are classified into four escalating stages, from intact skin to full thickness wounds with deep tissue…
- Conditions
- Pressure Ulcers Stage II, Pressure Ulcers Stage III, Pressure Ulcer, Stage IV
- Trial name
- NCT05496296
- Testing
- Altrazeal® Transforming Powder Dressing
- Where
- 14 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ULURU Inc.
Healthy Volunteer
A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers
This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and survival in healthy subjects.
- Trial name
- NCT01991990
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B Vaccine
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy.
- Trial name
- NCT00519649
- Testing
- Engerix™-B Kinder
- Where
- 35 sites in Germany
- Volunteers
- 301 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Autoimmune Diseases
Safety and Tolerability of GX-P1 in Healthy Male Volunteers
This study is a single-center, double-blind, placebo-controlled, phase I study with healthy male volunteers receiving ascending single dose of GX-P1
- Trial name
- NCT04298749
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genexine, Inc.