Clinical trials: Physiologic Effects of Drugs
Achondroplasia
A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia
Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN 111 in infants and young children with a diagnosis of achondroplasia.
- Trial name
- NCT03583697
- Testing
- BMN 111
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 75 people
- Sponsor
- BioMarin Pharmaceutical
Healthy
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262
- Trial name
- NCT05763459
- Testing
- ABBV-CLS-7262
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Calico Life Sciences LLC
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
Male Hypogonadism
Safety and Efficacy of Oral LPCN 1021 in Men With Low Testosterone or Hypogonadism
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Trial name
- SOAR (NCT02081300)
- Testing
- Oral testosterone undecanoate, LPCN 1021, Topical testosterone gel 1.62 %
- Volunteers
- 315 people
- Sponsor
- Lipocine Inc.
Area Under Curve, Pharmacokinetics
The Safety and Pharmacokinetics of Primapur and Gonal-f
The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa…
- Conditions
- Area Under Curve, Pharmacokinetics, Absorption
- Trial name
- NCT03857230
- Testing
- Follitropin alfa (Primapur), Follitropin alfa (Gonal-F)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IVFarma LLC
Virus Diseases, RNA Virus Infections
Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.
A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid…
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT01991561
- Testing
- Low dose of H5 VLP vaccine + Alhydrogel, Med dose of H5 VLP vaccine + Alhydrogel, High dose of H5 VLP vaccine + Alhydrogel
- Where
- 2 sites in Canada
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Medicago
Encephalitis, Encephalitis, Viral
Venezuelan Equine Encephalitis Monovalent Virus-Like Particle Vaccine
The primary objective of the study is to evaluate the safety and immunogenicity of non-adjuvanted and adjuvanted monovalent VEE VLP Vaccine in healthy adults (ages 18-50 years) when administered via intramuscular (IM) injection…
- Conditions
- Encephalitis, Encephalitis, Viral, Infectious Encephalitis, Virus Diseases
- Trial name
- VEEV (NCT03776994)
- Testing
- Vaccinations on Day 0, Day 28, and Day 140
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- SRI International
Complicated Intra-abdominal Infection
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
- Trial name
- RECLAIM3 (NCT01726023)
- Testing
- Ceftazidime-avibactam, metronidazole, Meropenem
- Where
- 30 sites in China, South Korea and 1 more
- Volunteers
- 486 people
- Sponsor
- Pfizer
Advanced Cancer, Cervical Cancer
A Study of AGEN2034 in Advanced Tumors and Cervical Cancer
This is a 2-part trial: a Phase 1, open-label, dose-escalation study in participants with metastatic or locally advanced solid tumors, with a consecutive Phase 2 expansion to evaluate efficacy in participants with recurrent…
- Trial name
- NCT03104699
- Testing
- AGEN2034
- Where
- 44 sites in United States, Australia and 7 more
- Volunteers
- 211 people
- Sponsor
- Agenus Inc.
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.
Peripheral Artery Disease (PAD)
Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
To compare the effect of ticagrelor versus aspirin on the change in peak walking time, evaluated on the graded treadmill test, from one to 26 weeks post-revascularization in patients with peripheral artery disease who have…
- Trial name
- TI-PAD EVR (NCT02227368)
- Testing
- Ticagrelor, Comparator
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Astrocytoma, Grade IV, Giant Cell Glioblastoma
Natural Killer Cell (CYNK-001) IV Infusion or IT Administration in Adults With Recurrent GBM
This study will find the maximum safe dose (MSD) or maximum tolerated dose (MTD) of CYNK-001 which are NK cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme, Cyclophosphamide
- Trial name
- CYNK001GBM01 (NCT04489420)
- Testing
- CYNK001-IV, CYNK001-IT
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Celularity Incorporated
Healthy
Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
The purpose of this study is to evaluate the safety and pharmacokinetics/pharmacodynamics of co-administration of Clomipramine HCl 15mg and Sildenafil citrate 100mg compared to the effects after single oral administration in…
- Trial name
- NCT02028598
- Testing
- Treatment 1, Treatment 2, Treatment 3
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- CTC Bio, Inc.
Diabetic Macular Edema
Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema
The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis®…
- Trial name
- OXEYE (NCT05697809)
- Testing
- OXU-001, Semi-automated suprachoroidal illuminated microcatheter, Ozurdex® Ophthalmic Intravitreal Implant
- Where
- 9 sites in United States, Puerto Rico
- Volunteers
- 3 people
- Sponsor
- Oxular Limited
Hereditary Angioedema (HAE)
Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers
This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.
- Trial name
- NCT02045264
- Testing
- Icatibant (30 mg)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shire
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
Virus Diseases, RNA Virus Infections
Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults
This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age.
- Conditions
- Virus Diseases, RNA Virus Infections, Respiratory Tract Diseases, Respiratory Tract Infections
- Trial name
- NCT03301051
- Testing
- Quadrivalent VLP Vaccine
- Where
- 73 sites in United States, Canada and 5 more
- Volunteers
- 10,160 people, healthy volunteers welcome
- Sponsor
- Medicago
Acute Pain
Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy Surgery
The purpose of this study is to determine the effectiveness and safety of single intravenous doses of the kappa opioid agonist CR845 in relieving pain in patients following laparoscopic-assisted hysterectomy surgery.
- Trial name
- NCT00877799
- Testing
- CR845
- Where
- 12 sites in United States
- Volunteers
- 114 people
- Sponsor
- Cara Therapeutics, Inc.
Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine…
- Trial name
- NCT00838578
- Testing
- KRN330, Irinotecan
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Kyowa Kirin Co., Ltd.
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