Clinical trials: Digestive Tract Diseases
Obesity, Metabolic Disease
Xla1 Christensenella Minuta, Phase I, Randomized, Partially Placebo-controlled Double-blind Protocol, Evaluating Safety, Tolerability and Impact on the Gut Microbiota in Healthy Volunteers, Overweight and Obese Adults
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults.
- Trial name
- CAUSALITY (NCT04663139)
- Testing
- Xla1
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- YSOPIA Bioscience
Advanced Solid Tumor, Non Small Cell Lung Cancer
A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A*03:01-positive adult patients with advanced solid tumors that harbor…
- Conditions
- Advanced Solid Tumor, Non Small Cell Lung Cancer, Pancreatic Carcinoma, Colorectal Cancer
- Trial name
- NCT07650357
- Testing
- CLSP-5282
- Where
- 4 sites in United States
- Volunteers
- 140 people
- Sponsor
- Clasp Therapeutics, Inc.
Alagille Syndrome
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching.
- Trial name
- NCT07585097
- Where
- 14 sites in France, Italy
- Volunteers
- 30 people
- Sponsor
- Ipsen
Gastrointestinal Cancer, Biliary Tract Cancer
Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase
Part 1: Dose-Escalation Phase (Phase 1b) The primary objective is to assess the safety and tolerability of increasing doses of D07001 softgel in patients with unresectable locally advanced or metastatic gastrointestinal (GI)…
- Trial name
- NCT03531320
- Testing
- D07001-softgel capsules
- Where
- 4 sites in Taiwan
- Volunteers
- 19 people
- Sponsor
- InnoPharmax Inc.
Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with…
- Conditions
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Adenocarcinoma, Pancreatic Ductal Adenocarcinoma (PDAC)
- Trial name
- NCT07349537
- Testing
- RMC-5127, daraxonrasib, cetuximab
- Where
- 9 sites in United States
- Volunteers
- 574 people
- Sponsor
- Revolution Medicines, Inc.
Alpha 1-Antitrypsin Deficiency
Evaluation of the Efficacy and Safety of VX-814 in Subjects With the PiZZ Genotype
This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-814 in PiZZ subjects.
- Trial name
- NCT04167345
- Testing
- VX-814
- Where
- 28 sites in United States, Canada and 2 more
- Volunteers
- 48 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Gut Health
A Study to Evaluate the Effects of a Butyrate-Polyphenol Formulation on Gut Health and Associated Symptoms
The purpose of the study is to evaluate the efficacy of a butyrate/polyphenol formulation on modulation of the gut microbiome and gastrointestinal symptoms using questionnaires in individuals with self-reported gastrointestinal…
- Trial name
- NCT07371975
- Testing
- Butyrate + Polyphenol Formulation
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Supplement Formulators, Inc.
Advanced Solid Tumor, Metastatic Solid Tumor
Study of WM-A1-3389 in Participants With Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer (MK-3475-E90/KEYNOTE-E90)
The purpose of the present study is to determine the safety, tolerability, and efficacy of WM-A1-3389 in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancer…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Lung Cancer, Colorectal Cancer
- Trial name
- NCT05872867
- Testing
- WM-A1-3389, Pembrolizumab
- Where
- 2 sites in South Korea
- Volunteers
- 54 people
- Sponsor
- Wellmarker Bio
Cystic Fibrosis Lung
4D-710 in Adult Patients With Cystic Fibrosis
This is a Phase 1/2 multicenter, open-label, single dose trial of 4D-710 investigational gene therapy in adults with cystic fibrosis.
- Trial name
- CF (NCT05248230)
- Testing
- 4D-710
- Where
- 20 sites in United States
- Volunteers
- 30 people
- Sponsor
- 4D Molecular Therapeutics
Solid Tumors
A Study to Evaluate the Safety, Tolerability, and Antitumor Activity of INCB001158 Plus Epacadostat, With or Without Pembrolizumab, in Advanced Solid Tumors
The purpose of this study is to assess the safety and antitumor activity of INCB001158 plus epacadostat, with or without pembrolizumab, in participants with advanced or metastatic solid tumors.
- Trial name
- NCT03361228
- Testing
- INCB001158, Epacadostat, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Incyte Corporation
Cystic Fibrosis
A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential…
- Trial name
- NCT01768663
- Testing
- Lumacaftor, Ivacaftor, Ciprofloxacin
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Pulmonary Valve Insufficiency, Pulmonary Regurgitation
COMPASSION - COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Regurgitation, Dysfunctional RVOT Conduit, Pulmonary Obstruction
- Trial name
- NCT00676689
- Testing
- SAPIEN Transcatheter Valve Implantation
- Where
- 7 sites in United States
- Volunteers
- 81 people
- Sponsor
- Edwards Lifesciences
Irritable Bowel Syndrome, Crohn Disease
Effect of UGIR in Adults With Compromised Gut Function and Malabsorption
This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.
- Conditions
- Irritable Bowel Syndrome, Crohn Disease, Ulcerative Colitis, Celiac Disease
- Trial name
- NCT03011593
- Testing
- Nutrition Support Product
- Volunteers
- 18 people
- Sponsor
- Metagenics, Inc.
Liposarcoma, Prostate Cancer
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy.
- Conditions
- Liposarcoma, Prostate Cancer, Advanced Breast Cancer, NSCLC (Non-small Cell Lung Cancer)
- Trial name
- CDK4i (NCT04557449)
- Testing
- PF-07220060, Letrozole, Fulvestrant
- Where
- 39 sites in United States, Argentina and 6 more
- Volunteers
- 430 people
- Sponsor
- Pfizer
Cholestasis, Intrahepatic
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
This will be a randomized, double-blind, placebo-controlled study to assess safety and tolerability of GSK2330672 administration in subjects with primary biliary cirrhosis (PBC) and symptoms of pruritus.
- Trial name
- NCT01899703
- Testing
- GSK2330672, Ursodeoxycholic acid
- Where
- 3 sites in United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis (CF)
Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.
- Trial name
- PreciSION CF (NCT07108153)
- Testing
- SION-719
- Where
- 13 sites in United States, Australia
- Volunteers
- 15 people
- Sponsor
- Sionna Therapeutics Inc.
Advance Solid Tumors, Colon and Rectal Cancer
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.
- Conditions
- Advance Solid Tumors, Colon and Rectal Cancer, Non - Small Cell Lung Cancer NSCLC, Pancreatic Adenocarcinoma Advanced or Metastatic
- Trial name
- NCT07610798
- Testing
- INV-8989
- Where
- China
- Volunteers
- 178 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Cystic Fibrosis, Burkholderia Infections
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection
The purpose of this research study was to determine if an experimental drug called Aztreonam for Inhalation Solution (AZLI) was safe and effective to treat Burkholderia lung infections in patients with cystic fibrosis (CF).
- Trial name
- NCT01059565
- Testing
- AZLI
- Where
- 35 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Gilead Sciences
Thyroid Cancer, Renal Cell Carcinoma
Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors
A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors
- Conditions
- Thyroid Cancer, Renal Cell Carcinoma, Non Small Cell Lung Cancer, Small-cell Lung Cancer
- Trial name
- NCT04234113
- Testing
- Nanrilkefusp alfa, Pembrolizumab
- Where
- 12 sites in United States, Czechia and 2 more
- Volunteers
- 115 people
- Sponsor
- SOTIO Biotech AG
Alpha 1-Antitrypsin Deficiency
A Study of KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
The Sponsor is developing KB408, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human SERPINA1 to the airways of people with alpha-1…
- Trial name
- Serpentine-1 (NCT06049082)
- Testing
- KB408 (Nebulization)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Krystal Biotech, Inc.
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