Clinical trials: Dose Finding Study
Acute Myocardial Infarction
Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel)…
- Trial name
- PACIFIC-AMI (NCT04304534)
- Testing
- BAY2433334
- Where
- 160 sites in United States, Austria and 12 more
- Volunteers
- 1,601 people
- Sponsor
- Bayer
Solid Cancers, Solid Tumor Cancer
A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors
The goal of this study is to obtain safety, tolerability, PK, and preliminary clinical antitumor activity for XL495 as a single agent and in combination with select cytotoxic agents in participants with locally advanced or…
- Conditions
- Solid Cancers, Solid Tumor Cancer, Solid Tumor Malignancy, Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)
- Trial name
- NCT06630247
- Testing
- XL495, ADC cytotoxic agents
- Where
- 10 sites in United States
- Volunteers
- 9 people
- Sponsor
- Exelixis
Gastric Cancer
Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients.
- Trial name
- NCT00072787
- Testing
- S-1, cisplatin
- Where
- 11 sites in United States
- Volunteers
- 41 people
- Sponsor
- Taiho Oncology, Inc.
Gout
Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001, evaluate its efficacy in lowering sUA and tophus burden, and identify the appropriate dose regimen for future studies in adult…
- Trial name
- NCT05690204
- Testing
- SAP-001
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 87 people
- Sponsor
- Shanton Pharma Pte. Ltd.
Solid Tumors, KRAS Mutation
A Study to Find a Safe and Effective Dose of BI 1701963 Alone and in Combination With BI 3011441 in Patients With Advanced Cancer and a Certain Mutation (Kirsten Rat Sarcoma Viral Oncogene Homologue [KRAS])
This is a study in adults with advanced cancer (solid tumours including non-small cell lung cancer and colorectal cancer) in whom previous chemotherapy was not successful.
- Trial name
- NCT04835714
- Testing
- BI 1701963, BI 3011441
- Where
- 4 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Boehringer Ingelheim
Neoplasms
A Safety and Dose-finding Study of JNJ-38877605 in Patients With Advanced or Refractory Solid Tumors.
This purpose of the study is to determine what dose of JNJ-38877605 is safe and if JNJ-38877605 has any effect in patients with advanced or refractory solid tumors for which there are not alternative therapies.
- Trial name
- NCT00651365
- Testing
- JNJ-38877605
- Volunteers
- 14 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Idiopathic Hypersomnia
A Study of TAK-360 in Adults With Idiopathic Hypersomnia
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night.
- Trial name
- NCT06812078
- Testing
- TAK-360
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 96 people
- Sponsor
- Takeda
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
- Trial name
- NCT02706834
- Testing
- TAK-828
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Asthma
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving…
- Trial name
- Umbriel (NCT06932263)
- Testing
- Tozorakimab
- Where
- 223 sites in United States, Argentina and 19 more
- Volunteers
- 540 people
- Sponsor
- AstraZeneca
Allergic Rhinitis, Allergic Rhinoconjunctivitis
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety.
- Trial name
- NCT01438463
- Testing
- PURETHAL Mites 6,667 AU/ml, PURETHAL Mites 20,000 AU/ml, PURETHAL Mites 50,000 AU/ml
- Where
- 35 sites in Austria, Belgium and 3 more
- Volunteers
- 290 people
- Sponsor
- HAL Allergy
Solid Tumor, Adult, Breast Cancer
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced…
- Conditions
- Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer
- Trial name
- NCT03149549
- Testing
- CX-2009
- Where
- 26 sites in United States, Netherlands and 2 more
- Volunteers
- 99 people
- Sponsor
- CytomX Therapeutics
Pulmonary Disease, Chronic Obstructive
Dose Finding Study in COPD
The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.
- Trial name
- NCT00122434
- Testing
- BEA 2180 BR, tiotropium
- Where
- 43 sites in United States, Belgium and 1 more
- Volunteers
- 389 people
- Sponsor
- Boehringer Ingelheim
Irritable Bowel Syndrome With Constipation
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with…
- Trial name
- NCT02559206
- Testing
- Linaclotide
- Where
- 71 sites in United States
- Volunteers
- 759 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Solid Tumor
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
This is a standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant…
- Trial name
- NCT01967043
- Testing
- Oraxol
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Kinex Pharmaceuticals Inc.
Atrial Fibrillation
Efficacy and Safety of MAA868 in Patients With Atrial Fibrillation
The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of MAA868 compared to apixaban in patients with atrial fibrillation.
- Trial name
- NCT03398434
- Testing
- MAA868, Apixaban
- Sponsor
- Novartis Pharmaceuticals
B-cell Lymphoma
INCB050465 in Combination With Rituximab, Bendamustine and Rituximab, or Ibrutinib in Participants With Previously Treated B-Cell Lymphoma (CITADEL-112)
The purpose of this study is to evaluate the safety and tolerability of parsaclisib when combined with rituximab, bendamustine and rituximab, or ibrutinib in participants with relapsed or refractory B-cell lymphoma.
- Trial name
- NCT03424122
- Testing
- Parsaclisib, Rituximab, Bendamustine
- Where
- 21 sites in United States, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Incyte Corporation
Venous Thromboembolism, Deep Vein Thrombosis
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
- Conditions
- Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty
- Trial name
- NCT01203072
- Testing
- DU-176b
- Where
- 2 sites in Japan
- Volunteers
- 523 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Healthy
A Study in Healthy Men to Find the Best Formulation for Once Daily Intake of Nintedanib
The main objective of this trial is to assess single dose drug exposure of several newly developed formulation prototypes of Nintedanib compared to Ofev® following oral administration.
- Trial name
- NCT05262751
- Testing
- Ofev®, Nintedanib formulation 1, Nintedanib formulation 2
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Parkinson Disease, Movement Disorders
Dyskinesia in Parkinson's Disease (Study P04501)
The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease.
- Conditions
- Parkinson Disease, Movement Disorders, Central Nervous System Diseases, Neurodegenerative Diseases
- Trial name
- NCT00406029
- Testing
- Preladenant, L-dopa, Other Parkinson's Disease treatments
- Volunteers
- 253 people
- Sponsor
- Merck Sharp & Dohme LLC
Advanced Solid Tumor
Study of DNP002 in Patients With Solid Tumors
This is an open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6…
- Trial name
- NCT06466265
- Testing
- DNP002
- Where
- South Korea
- Volunteers
- 36 people
- Sponsor
- Kumho HT Inc.
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