Clinical trials: Physiologic Effects of Drugs
Virus Diseases, RNA Virus Infections
Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.
A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT02022163
- Testing
- Low dose of H7 VLP vaccine + Alhydrogel, Med dose of H7 VLP vaccine + Alhydrogel, High dose of H7 VLP vaccine + Alhydrogel
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Medicago
Pertussis, Whooping Cough
Study of BPZE1 Intranasal Pertussis Vaccine (Administered Via VaxINator(TM)), Prime + Boost, in Healthy Adults
This study evaluates the safety and immunogenicity of the BPZE1 live attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares a single (prime) BPZE1 dose or BPZE1 2-dose…
- Trial name
- NCT03942406
- Testing
- BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- ILiAD Biotechnologies
Erectile Dysfunction
Study to Investigate Effect of a New Drug (PF-00446687) in Males Suffering From Erectile Dysfunction
The purpose of this study is to investigate the effect of up to 200 mg of PF-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.
- Trial name
- NCT00862888
- Testing
- PF-00446687, Sildenafil
- Where
- 3 sites in Norway, United Kingdom
- Volunteers
- 39 people
- Sponsor
- Pfizer
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Hypogonadism
Oral Testosterone for the Treatment of Hypogonadism
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors.
- Trial name
- NCT01717768
- Testing
- TSX-002
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- TesoRx Pharma, LLC
Non-small-cell Lung Cancer (NSCLC) Stage IV
A Phase III Trial of Recombinant Human Apo-2 Ligand for Injection
The trial is to evaluate the efficacy and safety of recombinant human Apo-2 ligand in treating patients with advanced retreated non-small cell lung cancer
- Trial name
- NCT03083743
- Testing
- Recombinant human Apo-2 ligand for Injection
- Where
- China
- Volunteers
- 417 people
- Sponsor
- Shanghai Gebaide Biotechnology Co., Ltd.
Physiological Effects of Drugs, Neoplasms by Histologic Type
Safety, Tolerability and Pharmacokinetics/Pharmacodynamics (PK/PD) of SHR-1603 in Subjects With Advanced Malignancies
SHR-1603-I-101 is an single-arm, open-label, dose finding phase I clinical trial of SHR-1603 in subjects with advanced solid tumor or relapsed/refractory malignant lymphoid diseases.
- Conditions
- Physiological Effects of Drugs, Neoplasms by Histologic Type, Lymphoma, Hematologic Neoplasms
- Trial name
- NCT03722186
- Testing
- SHR-1603
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Diabetes Mellitus, Diabetes Mellitus, Type 2
The Efficacy and Safety of DWP16001 in Combination With Metformin in T2DM Patients Inadequately Controlled on Metformin
Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP16001 in Combination with Metformin in Patients With Type 2 Diabetes Mellitus who Have Inadequate Glycemic Control on Metformin Alone.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Disease
- Trial name
- NCT05505994
- Testing
- DWP16001, Dapagliflozin
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Hodgkin Lymphoma
A Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Hodgkin Lymphoma
This phase 4, single-arm, open-label, multicenter study is designed to evaluate the efficacy and safety of brentuximab vedotin as a single agent in adult participants with histologically confirmed CD30+ relapsed or refractory…
- Trial name
- NCT01990534
- Testing
- Brentuximab Vedotin
- Where
- 18 sites in Czechia, Germany and 5 more
- Volunteers
- 60 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Stroke, Acute Stroke
The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
- Conditions
- Stroke, Acute Stroke, Ischemic Stroke, Cerebrovascular Disorders
- Trial name
- NCT07167550
- Testing
- Dimephosphon®
- Where
- 6 sites in Russia
- Volunteers
- 184 people
- Sponsor
- Tatchempharmpreparaty, JSC
Hypogonadism
Oral Testosterone for the Treatment of Hypogonadism in Males
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors.
- Trial name
- NCT02222558
- Testing
- TSX-002
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- TesoRx Pharma, LLC
Multiple Sclerosis
Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)
The aim of this retrospective study is to review and describe safety, tolerability and efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using information already recorded in medical records.
- Trial name
- REPLAY (NCT01207648)
- Testing
- Rebif®
- Where
- 18 sites in United States, Argentina and 6 more
- Volunteers
- 307 people
- Sponsor
- EMD Serono
Healthy
A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants
The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants.
- Trial name
- NCT05788328
- Testing
- Dabigatran etexilate (DE), Rosuvastatin, PF-07081532
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Asthma, Asthma, Bronchial
Mechanistic Study of Anti-inflammatory Effects of Fevipiprant in Patients With Eosinophilic Asthma.
This is an exploratory, randomized, subject- and investigator-blinded, placebo-controlled mode-of-action study to demonstrate the anti-inflammatory effects of fevipiprant compared to placebo after 12 weeks of treatment in 48…
- Conditions
- Asthma, Asthma, Bronchial, Bronchial Asthma, Eosinophilia
- Trial name
- NCT03989635
- Testing
- QAW039
- Sponsor
- Novartis Pharmaceuticals
Advanced Cancer
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors
The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors
- Trial name
- NCT03369223
- Testing
- BMS-986249, Nivolumab, Ipilimumab
- Where
- 45 sites in United States, Argentina and 9 more
- Volunteers
- 356 people
- Sponsor
- Bristol-Myers Squibb
Oestrogen Receptor Positive Advanced Breast Cancer
An Open Label Study of Postmenopausal Women With Oestrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Treated With Everolimus (RAD001) With Exemestane, With Exploratory Epigenetic Marker Analysis
Determine the overall response rate (ORR) at 48 weeks to everolimus (RAD001, 10mg daily p.o.) and exemestane (25mg daily p.o.) treatment in postmenopausal women with oestrogen receptor positive breast cancer who have previous…
- Trial name
- 4EVERUK (NCT01743560)
- Testing
- RAD001, Exemestane
- Where
- 11 sites in United Kingdom
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Angioedema
Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers
It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.
- Trial name
- NCT04557319
- Testing
- GNR-038, 25 МЕ/kg, GNR-038, 50 МЕ/kg, GNR-038, 100 МЕ/kg
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- AO GENERIUM
Hereditary Angioedema
Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema
It is a placebo-controlled randomized trial to evaluate the efficacy and safety of GNR-038 in comparison with Berinert® in patients with hereditary angioedema
- Trial name
- NCT04898309
- Testing
- GNR-038, 50 МЕ/ kg, GNR-038, 100 МЕ/ kg, Berinert®, 20 МЕ/ kg
- Where
- 5 sites in Russia
- Sponsor
- AO GENERIUM
Achondroplasia
Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia
This is a multicenter, multinational, randomized, active-controlled, operationally seamless Phase 2/3 study of BMN 333 in treatment-naïve pediatric participants with achondroplasia (ACH).
- Trial name
- ASPEN (NCT07441876)
- Testing
- BMN 333, Vosoritide Injection [Voxzogo]
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 160 people
- Sponsor
- BioMarin Pharmaceutical
Type 2 Diabetes Mellitus
Study of Dapagliflozin in Combination With Metformin XR to Initiate the Treatment of Type 2 Diabetes
The primary purpose of this study is to compare the change from baseline in hemoglobin A1C achieved with dapagliflozin 10 mg in combination with metformin XR as compared with metformin XR monotherapy and compared with…
- Trial name
- NCT00859898
- Testing
- Dapagliflozin, Metformin XR
- Where
- 123 sites in United States, India and 4 more
- Volunteers
- 1,093 people
- Sponsor
- AstraZeneca