Clinical trials: PD
Malignant Melanoma
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)
This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after prior therapy.
- Trial name
- NCT01704287
- Testing
- Pembrolizumab, Carboplatin, Paclitaxel
- Volunteers
- 540 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer
This research study is exploring chemotherapy in combination with immunotherapy (a therapy that uses the body's own immune system to control cancer) as a possible treatment for hormone receptor positive breast cancer.
- Trial name
- NCT02999477
- Testing
- Pembrolizumab, Nab-Paclitaxel, Biopsy
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Adrienne G. Waks
Non-small Cell Lung Cancer
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC)…
- Trial name
- NCT02220894
- Testing
- pembrolizumab, carboplatin, paclitaxel
- Volunteers
- 1,274 people
- Sponsor
- Merck Sharp & Dohme LLC
Pharmacokinetics, Pharmacodynamics
Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers
This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of…
- Trial name
- NCT05539872
- Testing
- I004, NovoLog
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Amphastar Pharmaceuticals, Inc.
Gastroesophageal Reflux
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
- Trial name
- NCT00362609
- Testing
- pantoprazole
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 59 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Advanced/Metastatic Solid Tumors
Study of Selumetinib (MK-5618) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (MK-5618-001)
This study will examine the safety, pharmacokinetics, and efficacy of escalating doses of selumetinib (MK-5618) in combination with intravenous (IV) pembrolizumab (MK-3475) for participants with advanced / metastatic solid tumors.
- Trial name
- NCT03833427
- Testing
- Selumetinib, Pembrolizumab
- Where
- 6 sites in United States, Canada
- Volunteers
- 32 people
- Sponsor
- Merck Sharp & Dohme LLC
Urothelial Cancer
A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma
Background: Metastatic urothelial carcinoma is lethal and has no cure. Response rates to current treatments are modest. Researchers want to find new strategies to treat the disease.
- Trial name
- NCT04501094
- Testing
- Bintrafusp alfa (M7824)
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- National Cancer Institute (NCI)
Healthy Volunteers
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
The purpose of this study is to learn about a drug-drug interaction. When two medications are taken together at the same time, one medication may change the activity of the other medication in the body - this is called a…
- Trial name
- NCT03655301
- Testing
- Copanlisib (Aliqopa, BAY80-6946), Metformin
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Bayer
Diabetes Mellitus, Type 2
Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.
- Trial name
- NCT00372957
- Testing
- GW823093 15mg, GW823093 30mg
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Squamous Cell Carcinoma of Head and Neck
A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the…
- Trial name
- SKYSCRAPER-09 (NCT04665843)
- Testing
- Atezolizumab, Tiragolumab
- Where
- 47 sites in United States, Czechia and 11 more
- Volunteers
- 123 people
- Sponsor
- Hoffmann-La Roche
Kidney Transplantation
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients
This study was to compare CFZ533 to tacrolimus (TAC) in prevention of organ rejection in kidney transplant.
- Trial name
- CIRRUS I (NCT03663335)
- Testing
- CFZ533 - Cohort 1/Cohort 2, Mycophenolate Mofetil (MMF), Corticosteroids (CS)
- Where
- 74 sites in United States, Argentina and 18 more
- Volunteers
- 418 people
- Sponsor
- Novartis Pharmaceuticals
Ovarian Neoplasms
Efficacy and Safety Study of Pembrolizumab (MK-3475) in Participants With Advanced Recurrent Ovarian Cancer (MK-3475-100/KEYNOTE-100)
This study will assess the efficacy and safety of pembrolizumab (MK-3475) monotherapy in female participants with recurrent ovarian cancer (ROC) who have received up to 5 prior lines of treatment including platinum-based…
- Trial name
- NCT02674061
- Testing
- Pembrolizumab
- Volunteers
- 376 people
- Sponsor
- Merck Sharp & Dohme LLC
Ovarian Cancer, Carcinoma, Ovarian Epithelial
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation…
- Conditions
- Ovarian Cancer, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
- Trial name
- NCT05116189
- Testing
- Pembrolizumab, Paclitaxel, Bevacizumab
- Where
- 187 sites in United States, Australia and 23 more
- Volunteers
- 643 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment, Liver Diseases
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined…
- Conditions
- Hepatic Impairment, Liver Diseases, Digestive System Diseases
- Trial name
- NCT02121860
- Testing
- IDN-6556
- Where
- 3 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Conatus Pharmaceuticals Inc.
Parkinson's Disease
Highly Challenging Balance Program to Reduce Fall Rate in PD
This study will test the hypothesis that two highly challenging exercise programs, one based at the VA medical center and the other conducted remotely, will both significantly reduce overall fall rates in patients with…
- Trial name
- NCT03972969
- Testing
- Facility-based structured exercise, Home-based structured exercise, Health education
- Where
- United States
- Volunteers
- 162 people
- Sponsor
- VA Office of Research and Development
Biliary Atresia
Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy
This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy).
- Trial name
- NCT06121375
- Testing
- OCA
- Where
- 24 sites in Australia, Canada and 8 more
- Volunteers
- 28 people
- Sponsor
- Intercept Pharmaceuticals
Parkinson Disease
Airway Protective Mechanisms in PD (R01)
This study will collect data on various aspects of airway sensation and function, and determine how it relates to the development of swallowing and cough dysfunction in Parkinson's disease.
- Trial name
- NCT03321019
- Testing
- Capsaicin, Resistive respiratory loads, Event-related evoked potential using electroencephalography (EEG).
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- University of Florida
ADHD
Atomoxetine PBPK-PD Clinical Study
The primary aims of this study focus on characterizing the relationship between atomoxetine exposure and clinical outcomes, as assessed by standardized measures.
- Trial name
- NCT03154359
- Testing
- Atomoxetine Hydrochloride
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Children's Mercy Hospital Kansas City
Anesthesia
A PK/PD Study of Fospropofol Disodium Compared With Propofol Injectable Emulsion
This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol.
- Trial name
- NCT01260142
- Testing
- Fospropofol disodium, propofol
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Severe Uncontrolled Asthma
PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
This study will evaluate the PK, PD and long-term safety of Benralizumab administered subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma.
- Trial name
- TATE (NCT04305405)
- Testing
- Benralizumab
- Where
- 15 sites in United States, Japan
- Volunteers
- 30 people
- Sponsor
- AstraZeneca