Clinical trials: Phase 1
Attention Deficit Disorder With Hyperactivity
Neuroimaging of Diet in ADHD: Phase I
Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period.
- Trial name
- FTF (NCT01862484)
- Testing
- Restricted Diet, Ruse Diet
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
SARS-CoV-2, Influenza
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
- Trial name
- NCT05375838
- Testing
- mRNA-1073, mRNA-1010, mRNA-1273
- Where
- 14 sites in United States
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Recurrent Malignant Solid Neoplasm, Recurrent Melanoma
Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
This phase I trial studies the side effects and best dose of cabozantinib S-malate in treating younger patients with solid tumors that have come back or no longer respond to treatment.
- Conditions
- Recurrent Malignant Solid Neoplasm, Recurrent Melanoma, Recurrent Primary Central Nervous System Neoplasm, Recurrent Thyroid Gland Carcinoma
- Trial name
- NCT01709435
- Testing
- Cabozantinib S-malate, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 23 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- National Cancer Institute (NCI)
Gastrointestinal Motility Disorder
A Phase 1, Multiple Intravenous Dose Study to Examine Safety, Tolerability, and PK of Intravenous TD-8954, a 5-HT4 Receptor Agonist, in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics (PK) of repeated IV doses of TD-8954 in healthy adults 18 to 45 years of age and healthy…
- Trial name
- NCT01644240
- Testing
- TD-8954
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Long Bone Delayed-Union Fracture
Phase 1/2a Study on Allogeneic Osteoblastic Cells Implantation in Delayed-Union Fractures
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone.
- Trial name
- NCT02020590
- Testing
- ALLOB® implantation
- Volunteers
- 25 people
- Sponsor
- Bone Therapeutics S.A
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.
Solid Tumors, Hematologic Malignancies
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment
The purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing.
- Conditions
- Solid Tumors, Hematologic Malignancies, Hepatic Impairment
- Trial name
- NCT01949545
- Testing
- Carfilzomib
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 46 people
- Sponsor
- Amgen
Healthy Volunteers
A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in…
- Trial name
- NCT03918239
- Testing
- SHP643
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Shire
Cancer Of Prostate, Prostate Neoplasms
Highly Conformal, Hypofractionated, Focally Dose Escalated Post-Prostatectomy Radiotherapy
Background: Sometimes prostate cancer comes back after a person's prostate is removed. In this case, radiation is a common treatment. Radiation kills prostate cancer cells. It can be very effective.
- Conditions
- Cancer Of Prostate, Prostate Neoplasms, Prostate Cancer, Neoplasms of Prostate
- Trial name
- NCT03388619
- Testing
- Prostate bed with integrated boost, Prostate bed irradiation only, Whole Body Bone Scan
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
Stroke
Niche Trial: Navigated Inhibitory rTMS to Contralesional Hemisphere Trial
A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be…
- Trial name
- NICHE (NCT02089464)
- Testing
- NBS-guided rTMS, Task oriented rehabilitation
- Where
- 12 sites in United States
- Volunteers
- 199 people
- Sponsor
- Nexstim Ltd
Glioblastoma, MGMT-Unmethylated Glioblastoma
Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
This Phase I study investigated the side-effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly-diagnosed O6-methylguanine-DNA methyltransferase…
- Trial name
- NCT03250299
- Testing
- Microtubule-Targeted Agent BAL101553, Radiation Therapy
- Where
- 8 sites in United States
- Volunteers
- 26 people
- Sponsor
- Basilea Pharmaceutica
Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific
Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma
This phase I trial is studying the side effects and best dose of giving ridaforolimus and vorinostat together in treating patients with advanced solid tumors or lymphoma.
- Trial name
- NCT01169532
- Testing
- ridaforolimus, vorinostat, biopsy
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Fox Chase Cancer Center
Multiple Myeloma
Carfilzomib With Bendamustine and Dexamethasone in Multiple Myeloma
This study is designed to define dose-limiting toxicity and determine preliminary evidence of efficacy of carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients with newly diagnosed multiple myeloma…
- Trial name
- NCT02002598
- Testing
- Bendamustine, Carfilzomib, Dexamethasone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Suzanne Lentzsch, MD
HIV Infections
Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART
The purpose of this study was to evaluate the safety and immunotherapeutic activity of an anti-PD-1 antibody (cemiplimab) in participants with HIV-1 on suppressive combination antiretroviral therapy (cART).
- Trial name
- NCT03787095
- Testing
- Cemiplimab
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chikungunya Virus
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
- Trial name
- NCT03325075
- Testing
- VAL-181388
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Nucleophosmin 1-mutated Acute Myeloid Leukemia
Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML
The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as…
- Trial name
- NCT05020665
- Testing
- Entospletinib, Cytarabine, Anthracycline
- Where
- 83 sites in United States, Brazil and 10 more
- Volunteers
- 15 people
- Sponsor
- Kronos Bio
HER2-mutant Non-Small Cell Lung Cancer
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.
- Trial name
- DL-05 (NCT05246514)
- Testing
- Trastuzumab deruxtecan
- Where
- 28 sites in China
- Volunteers
- 72 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Type 1
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.
- Trial name
- NCT02038764
- Testing
- PF-06342674 Dose A, PF-06342674 Dose B, PF-06342674 Dose C
- Where
- 21 sites in United States
- Volunteers
- 37 people
- Sponsor
- Pfizer
Healthy
Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.
- Trial name
- NCT02232087
- Testing
- Salmeterol, fluticasone propionate
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Kindeva Drug Delivery
Rare Diseases
A Study to Evaluate Emapalumab in Japanese Healthy Volunteers.
This is a randomized, placebo controlled and double-blinded study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single dose (1 mg/kg) of emapalumab in adult healthy Japanese subjects.
- Trial name
- NCT04765553
- Testing
- NI-0501, Saline
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum