Clinical trials: PD
Non-alcoholic Fatty Liver Disease
Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH
The purpose of this study is to understand how the drug GSK4532990 is processed in the body (pharmacokinetics) and how it works in the liver (pharmacodynamics) as well as to ensure it is safe and well-tolerated.
- Trial name
- SKYLINE (NCT06104319)
- Testing
- GSK4532990
- Where
- 14 sites in United States
- Volunteers
- 61 people
- Sponsor
- GlaxoSmithKline
Advanced Cancer
A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)
This is a Phase 1b/2 dose-optimization study to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of avelumab (MSB0010718C) in combination with other cancer immunotherapies in patients with…
- Trial name
- NCT02554812
- Testing
- Avelumab, Utomilumab, PF-04518600
- Where
- 88 sites in United States, Australia and 6 more
- Volunteers
- 409 people
- Sponsor
- Pfizer
Non-Small Cell Lung Cancer
A Study of Atezolizumab in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Participants Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower 132)
This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or…
- Trial name
- NCT02657434
- Testing
- Atezolizumab, Carboplatin, Cisplatin
- Where
- 183 sites in United States, Argentina and 25 more
- Volunteers
- 578 people
- Sponsor
- Hoffmann-La Roche
Advanced/Metastatic Melanoma
Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)
This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone…
- Trial name
- NCT04152863
- Testing
- Gebasaxturev IV, Gebasaxturev ITu, Pembrolizumab
- Where
- 30 sites in United States, Australia and 9 more
- Volunteers
- 85 people
- Sponsor
- Merck Sharp & Dohme LLC
Mesothelioma
A Study of Pembrolizumab in Combination With Cisplatin and Pemetrexed in Advanced Malignant Pleural Mesothelioma (MPM) (MK-3475-A17)
This is a multicenter, open-label, non-randomized, study of pembrolizumab in combination with cisplatin and pemetrexed in treatment of naïve participants with a histologically confirmed diagnosis of advanced/unresectable…
- Trial name
- NCT04153565
- Testing
- Pembrolizumab, Pemetrexed, Cisplatin
- Where
- 4 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects
GSK3389404 is being developed for the treatment of CHB virus infection. The development goal for GSK3389404 is the establishment of a finite duration treatment that results in sustained suppression of hepatitis B virus (HBV)…
- Trial name
- NCT03020745
- Testing
- GSK3389404
- Where
- 21 sites in China, Hong Kong and 4 more
- Volunteers
- 78 people
- Sponsor
- GlaxoSmithKline
Asthma
A Study of Itolizumab (EQ001) to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity in Uncontrolled Asthma
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with moderate-to-severe asthma.
- Trial name
- EQUIP (NCT04007198)
- Testing
- EQ001
- Where
- 13 sites in Australia, New Zealand
- Volunteers
- 18 people
- Sponsor
- Biocon Limited
X-Linked Hypophosphatemia
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
The primary objectives of the study are to: Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers…
- Trial name
- NCT02750618
- Testing
- Burosumab
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Kyowa Kirin, Inc.
Cancer, Solid Tumor
Study of Pembrolizumab (MK-3475) in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001/KEYNOTE-001)
The present study has 5 parts. In Parts A and A1, the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated from 1 to 10 mg/kg to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for…
- Trial name
- KEYNOTE-001 (NCT01295827)
- Testing
- Pembrolizumab
- Volunteers
- 1,260 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Rare Malignant Solid Neoplasm, Rare Malignant Solid Neoplasm
Testing the Combination of Anti-cancer Drugs Atezolizumab and Tiragolumab in People With Advanced Stage Rare Cancers, RARE3 Trial
This phase II trial tests how well atezolizumab works in combination with tiragolumab in treating patients with rare solid tumors that may have spread from where they first started to nearby tissue, lymph nodes, or distant parts…
- Conditions
- Advanced Rare Malignant Solid Neoplasm, Rare Malignant Solid Neoplasm, Refractory Rare Malignant Solid Neoplasm
- Trial name
- NCT05715281
- Testing
- Atezolizumab, Biopsy Procedure, Biospecimen Collection
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Non-Small Cell Lung Cancer
Efficacy and Safety of Pembrolizumab (MK-3475) With Lenvatinib (E7080/MK-7902) vs. Docetaxel in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after…
- Trial name
- NCT03976375
- Testing
- Pembrolizumab, Lenvatinib, Docetaxel
- Where
- 143 sites in United States, Argentina and 16 more
- Volunteers
- 422 people
- Sponsor
- Merck Sharp & Dohme LLC
Carcinoma, Non-Small-Cell Lung
Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (MK-3475-598/KEYNOTE-598)
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC).
- Trial name
- NCT03302234
- Testing
- Pembrolizumab, Ipilimumab
- Where
- 187 sites in United States, Argentina and 22 more
- Volunteers
- 568 people
- Sponsor
- Merck Sharp & Dohme LLC
Cancer of Pancreas, Pancreas Cancer
M7824 (MSB0011359C) in Combination With Gemcitabine in Adults With Previously Treated Advanced Adenocarcinoma of the Pancreas
Background: Pancreas cancer ranks 4th in all cancer-related deaths in the United States (U.S.) Gemcitabine is a standard treatment for it.
- Conditions
- Cancer of Pancreas, Pancreas Cancer, Pancreatic Adenocarcinoma, Pancreatic Cancer
- Trial name
- NCT03451773
- Testing
- M7824, Gemcitabine
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- National Cancer Institute (NCI)
Carcinoma, Small Cell, Lung Cancer
M7824 and Topotecan or Temozolomide in Relapsed Small Cell Lung Cancers
BACKGROUND: Small cell lung cancer (SCLC) is an aggressive cancer with a poor prognosis. Although highly responsive to chemotherapy initially, SCLC relapses quickly and becomes refractory to treatment within a few months.
- Conditions
- Carcinoma, Small Cell, Lung Cancer, Small Cell Lung Cancer
- Trial name
- NCT03554473
- Testing
- M7824, Topotecan, Temozolomide
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
Lymphoma, B-Cell
A Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-A33/KEYNOTE-A33)
The purpose of this study is to evaluate the objective response, safety, and tolerability of pembrolizumab in Japanese participants who have refractory primary mediastinal large B-cell lymphoma.
- Trial name
- NCT04317066
- Testing
- Pembrolizumab
- Where
- 9 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State
The primary objective of the trial is to investigate the pharmacokinetics and pharmacodynamics of idarucizumab in Chinese healthy male and female subjects following intravenous administration of idarucizumab followed by…
- Trial name
- NCT03086356
- Testing
- Dabigatran etexilate, Idarucizumab
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Boehringer Ingelheim
Iron Deficiency Anemia (IDA)
A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA
This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after…
- Trial name
- NCT02410213
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- 10 sites in Poland, Russia
- Volunteers
- 35 people
- Sponsor
- American Regent, Inc.
Parkinson's Disease
Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon
This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with…
- Trial name
- NCT01568073
- Testing
- BIA 9-1067, Entacapone, Levodopa
- Where
- Portugal
- Volunteers
- 600 people
- Sponsor
- Bial - Portela C S.A.
Kidney Transplantation
CCFZ533X2201 - PoC Study in de Novo Renal Transplantation
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and potential for CFZ533 to replace calcineurin inhibitors (CNI), while providing a similar rate of acute rejection prophylaxis and…
- Trial name
- NCT02217410
- Testing
- CFZ533, Tacrolimus (Tac), Mycophenolate mofetil (MMF)
- Where
- 14 sites in United States, Brazil and 2 more
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals
Hypertension
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than Adalat CR (controlled release), if taken…
- Trial name
- NCT00768560
- Testing
- Nifedipine (Adalat CR, BAYA1040) 80mg OD, Nifedipine (Adalat CR, BAYA1040) 40mg BID, Nifedipine (Adalat CR, BAYA1040) 40mg OD
- Where
- 3 sites in Japan
- Volunteers
- 35 people
- Sponsor
- Bayer