Clinical trials: Phase I
Healthy Subjects
THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC
This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC…
- Trial name
- NCT02625207
- Testing
- Maraviroc (Part 1), Maraviroc (Part 2), Darunavir/cobicistat (Part 2)
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Melanoma, Lung Cancer
Evaluating the Combination of MK-3475 and Sterotactic Body Radiotherapy in Patients With Metastatic Melanoma or NSCLC
This is a 2-part prospective trial examining the ability of Stereotactic Body Radiation Therapy (SBRT) to induce a response to MK-3475, a humanized antibody to PD-1, in patients who progress on this antibody.
- Trial name
- NCT02407171
- Testing
- MK-3475, Stereotactic Body Radiation Therapy (SBRT)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Yale University
Lung Adenocarcinoma, Lung Cancer
A Phase 1/2 Trial of Trametinib and Erlotinib in Patients With EGFR-Mutant Lung Adenocarcinomas and Acquired Resistance to Erlotinib
The purpose of this study is to determine the safety, tolerability and overall response rate of trametinib when given in combination with erlotinib in patients with Stage IV or recurrent lung adenocarcinoma that cannot be treated…
- Conditions
- Lung Adenocarcinoma, Lung Cancer, Lung Cancer Metastatic, Lung Cancer Stage IV
- Trial name
- NCT03076164
- Testing
- Trametinib, Erlotinib
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Neoplasms
GSK3359609 Plus Tremelimumab for the Treatment of Advanced Solid Tumors
The purpose of this study is to evaluate if the combination of GSK3359609 and tremelimumab is safe and tolerable (Part 1) and provides significant survival benefit to subjects with relapsed/refractory (R/R) Head and Neck Squamous…
- Trial name
- NCT03693612
- Testing
- feladilimab, Tremelimumab, Docetaxel
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 26 people
- Sponsor
- GlaxoSmithKline
Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma
Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas
This phase I trial studies the side effects and best dose of alisertib when combined with fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have returned after previous treatment with…
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Ependymoma, Adult Anaplastic Oligodendroglioma, Adult Brain Stem Glioma
- Trial name
- NCT02186509
- Testing
- Hyperfractionated radiation therapy, Stereotactic radiosurgery, Alisertib
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Atopic Dermatitis
A Phase I Study of HY209 Gel in Healthy Male Volunteers for Atopic Dermatitis
A randomized, double-blind, placebo-controlled single and multiple dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 gel after transdermal administration in…
- Trial name
- Shaperon (NCT03492398)
- Testing
- HY209
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Shaperon
Age-Related Macular Degeneration
Alpha Lipoic Acid in Geographic Atrophy
Because of its iron-chelating and antioxidant properties, alpha lipoic acid may be a treatment for geographic atrophy (GA) secondary to age-related macular degeneration.
- Trial name
- ALA (NCT02613572)
- Testing
- alpha lipoic acid
- Where
- 5 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania
Hypogonadism
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection…
- Trial name
- NCT03792477
- Testing
- Test formulation, Reference formulation
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pfizer
RSV Infection
Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children
The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of a single dose of recombinant, live-attenuated respiratory syncytial virus (RSV) vaccines (RSV 6120/∆NS1 or RSV 6120/F1/G2/∆NS1) in…
- Trial name
- NCT03596801
- Testing
- RSV 6120/∆NS1, RSV 6120/F1/G2/∆NS1
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Pompe Disease
Safety and Efficacy of Albuterol in Individuals With Late-onset Pompe Disease
In this study the study team proposes to investigate the efficacy of albuterol on motor function of individuals with Late Onset Pompe Disease (LOPD) who are receiving enzyme replacement therapy, given albuterol was well-tolerated…
- Trial name
- NCT01885936
- Testing
- Albuterol
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Duke University
Bioavailability
Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects
This is a single center, Phase 1, randomized, open-label, single-dose, 4 treatment, 4-period, 4-sequence, crossover study designed to compare the pharmacokinetics (PK) of sapropterin from the Test and Reference products, and to…
- Trial name
- NCT06481709
- Testing
- RLF-OD032, Kuvan
- Where
- Canada
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- APR Applied Pharma Research s.a.
Urinary Bladder Cancer, Melanoma
MAGE-A4ᶜ¹º³²T for Multi-Tumor
This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung…
- Conditions
- Urinary Bladder Cancer, Melanoma, Head and Neck Cancer, Ovarian Cancer
- Trial name
- NCT03132922
- Testing
- Autologous genetically modified MAGE-A4ᶜ¹º³²T cells, Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation
- Where
- 11 sites in United States, Canada
- Volunteers
- 71 people
- Sponsor
- USWM CT, LLC
Non-Small Cell Lung Cancer (NSCLC)
Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer
This research study is evaluating two drugs, alectinib and bevacizumab, as possible treatments for Advanced Non-Small Cell Lung Cancer (NSCLC).
- Trial name
- NCT02521051
- Testing
- Alectinib, Bevacizumab
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Massachusetts General Hospital
Posttraumatic Stress Disorder
MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD
The goal of this clinical trial is to learn if cognitive-behavioral conjoint therapy (CBCT) in combination with MDMA-assisted therapy is safe and effective in people with chronic PTSD and their partners.
- Trial name
- NCT02876172
- Testing
- MDMA, CBCT, Therapy
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Resilient Pharmaceuticals
Healthy
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers
- Trial name
- NCT01681277
- Testing
- BI 113608 PIB bid, BI 113608 PIB qd
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Carcinoma, Basal Cell
Treatment Duration Increment and Pharmacodynamic Study of CX-4945 in Patients With Basal Cell Carcinoma (BCC)
This study is to determine the recommended phase II dose (RP2D) and schedule of CX-4945 when administered orally twice daily for 28 consecutive days, in a 4-week (28 days) cycle, in patients with locally advanced or metastatic…
- Trial name
- NCT03897036
- Testing
- CX-4945
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- Senhwa Biosciences, Inc.
Lymphoma, Non-Hodgkin
A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma
This study is about a medicine called TAK-981 given with rituximab, used to treat adults with relapsed or refractory CD20-positive non-Hodgkin lymphoma. This study has 2 parts.
- Trial name
- NCT04074330
- Testing
- TAK-981, Rituximab
- Where
- 59 sites in United States, Canada and 7 more
- Volunteers
- 38 people
- Sponsor
- Takeda
Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and…
- Trial name
- NCT02005211
- Testing
- AZD3293
- Where
- Japan
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy, Chronic Rhinosinusitis With Nasal Polyps
Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with…
- Conditions
- Healthy, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis
- Trial name
- NCT02743871
- Testing
- PF-06817024
- Where
- 20 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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