Clinical trials: Phase I
Healthy
Relative Drug Exposures Of Two Formulations of PF-02341066
The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over, single-dose study employing administration of two PF-02341066 formulations in the fasted state to healthy adult volunteers.
- Trial name
- NCT00939731
- Testing
- PF-02341066
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults
The main aim of this study is to check how well healthy adults can tolerate TAK-881 with different dosing schedules. During the study, participants will receive one infusion of TAK-881 under the skin (subcutaneous [SC] infusion)…
- Trial name
- NCT06935266
- Testing
- TAK-881, SC Investigational Needle Sets
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Takeda
Inflammatory Bowel Diseases, Ulcerative Colitis
Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30…
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- Trial name
- NCT02330653
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Stacy A. Kahn
Helicobacter Pylori
A Study of Vonoprazan in Adults With Helicobacter Pylori
Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other parts of the digestive system.
- Trial name
- NCT04753437
- Testing
- Clarithromycin, Amoxicillin, Bismuth potassium citrate
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Takeda
Chronic Myeloproliferative Disorders, Graft Versus Host Disease
Cyclosporine Eye Drops in Preventing Graft-Versus-Host Disease of the Eye in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer or Bone Marrow Failure Disorder
RATIONALE: Cyclosporine eye drops may prevent graft-versus-host disease of the eye in patients who have undergone donor stem cell transplant for hematologic cancer or bone marrow failure disorder.
- Conditions
- Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma
- Trial name
- NCT00755040
- Testing
- cyclosporine ophthalmic emulsion
- Where
- 5 sites in United States
- Volunteers
- 164 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Healthy
A Study in Healthy Men to Test How BI 1291583 is Processed in the Body
The main objective of this trial is to Assess the mass balance and total recovery of [14C]-radioactivity in urine and faeces following a dose of BI 1291583 (C-14) Provide plasma and urine samples for pharmacokinetic…
- Trial name
- NCT05833035
- Testing
- BI 1291583 mixed with [C-14] BI 1291583
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bipolar Depression
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major…
- Trial name
- NCT03249376
- Testing
- Lumateperone
- Where
- 47 sites in United States, Bulgaria and 4 more
- Volunteers
- 381 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Relapsed or Refractory Solid Tumors, Nonsmall Cell Lung Cancer
Phase I/II Study of Lenalidomide Plus Pembrolizumab in Patients With Solid Tumors With Expansion in Non-small Cell Lung Cancer
For the phase I component of the trial a classic 3 + 3 dose escalation design will be utilized, with a fixed dose of pembrolizumab and an escalating dose of the lenalidomide.
- Trial name
- NCT02963610
- Testing
- Lenalidomide, Pembrolizumab
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Fox Chase Cancer Center
Hyperemia Eye
Safety and Tolerability of PRO-185
Phase I Study to evaluate safety and tolerability of PRO-185 (naphazoline/hypromellose) ophthalmic solution through evaluation of vital signs, ocular signs such as intraocular pressure, hyperemia and mydriasis and adverse events.
- Trial name
- PRO-185 (NCT05470868)
- Testing
- Naphazoline / Hypromellose Ophthalmic
- Where
- Mexico
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Laboratorios Sophia S.A de C.V.
Advanced Solid Tumors, Solid Tumors
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft…
- Conditions
- Advanced Solid Tumors, Solid Tumors, Ovarian Cancer, Breast Cancer
- Trial name
- NCT04672460
- Testing
- TALZENNA capsule, Talazoparib soft gel capsule
- Where
- 31 sites in United States, Australia
- Volunteers
- 73 people
- Sponsor
- Pfizer
Myelodysplastic Syndrome
Safety and Pharmacokinetics Study of SyB L-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS)
The purpose of this study is to investigate tolerability when SyB L-1101 is administered intravenously in patients with recurrent/relapsed or refractory myelodysplastic syndrome, to determine the dose-limiting toxicity and…
- Trial name
- NCT01700335
- Testing
- SyB L-1101
- Where
- 3 sites in Japan
- Volunteers
- 9 people
- Sponsor
- SymBio Pharmaceuticals
Malaria
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...
Background: Malaria remains a major global health problem. Malaria is spread by the bite of mosquitos. Africa is the region of the world where most people get malaria. Sanaria PfSPZ Challenge is a malaria vaccine.
- Trial name
- NCT03952650
- Testing
- Chloroquine Phosphate, PfSPZ Challenge, Pyrimethamine
- Where
- Mali
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Volunteers
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.
- Trial name
- NCT05134350
- Testing
- LOXO-305, Omeprazole
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
Oblimersen Sodium & Combination Chemotherapy in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Conditions
- Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Stage I Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma
- Trial name
- NCT00736450
- Testing
- oblimersen sodium, rituximab, cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- University of Nebraska
Healthy Volunteers, Adult
A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants
The purpose of this study is to compare if two forms of study medicine, Ritlecitinib, get processed differently in healthy adults.
- Conditions
- Healthy Volunteers, Adult, Pharmacokinetics
- Trial name
- NCT05852340
- Testing
- Ritlecitinib
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Participants
Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants
The purpose of this study is to estimate the effect PF-07321332/Ritonavir and Ritonavir on Midazolam (a cytochrome P450 [CYP]3A4 substrate) in Healthy Adult Participants.
- Trial name
- NCT05032950
- Testing
- Midazolam, PF-07321332/ritonavir + Midazolam, Ritonavir + Midazolam
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Severe Acute Respiratory Syndrome, Coronavirus
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Trial name
- NCT04449276
- Testing
- CVnCoV Vaccine
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- CureVac
Advanced Malignancies
Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced Malignancies
The primary objective is to assess the safety and tolerability of Toripalimab in subjects with various advanced malignancies and to evaluate the recommended Phase 2 dose.
- Trial name
- NCT03474640
- Testing
- Part A, Part B
- Where
- 14 sites in United States
- Volunteers
- 184 people
- Sponsor
- TopAlliance Biosciences
Sickle Cell Disease
A Phase 1 Study of Continuous Intravenous L-citrulline During Sickle Cell Pain Crisis or Acute Chest Syndrome
Sickle cell disease is a genetic red blood cell disorder characterized by vaso-occlusion from sickling of red blood cells, that can lead to pain or organ complications such as acute chest syndrome.
- Trial name
- NCT02697240
- Testing
- Intravenous citrulline
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Mississippi Medical Center
COVID-19
A Study of Silmitasertib (CX-4945) in Healthy Subject
This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy…
- Trial name
- NCT05817708
- Testing
- CX-4945
- Where
- Taiwan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Senhwa Biosciences, Inc.
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