Clinical trials: Safety and Pharmacokinetics
Heart Failure, Worsening Heart Failure (WHF)
To Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)
This Study Aims to Evaluate the Safety, Tolerability and Efficacy of R2R01 Combined With SOC as Compared to SOC Alone in Outpatients With Worsening Heart Failure (WHF)
- Trial name
- NCT06264310
- Testing
- R2R01
- Where
- 8 sites in United States
- Volunteers
- 33 people
- Sponsor
- River 2 Renal Corp.
Hodgkin's Lymphoma
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma
The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
- Trial name
- SAPHIRE (NCT01037478)
- Testing
- Resminostat (4SC-201)
- Where
- 10 sites in Czechia, Poland and 1 more
- Volunteers
- 37 people
- Sponsor
- 4SC AG
Multiple Myeloma
Evaluation of Pharmacokinetics, Safety, and Preliminary Efficacy of Isatuximab in Chinese Patients With Relapsed and/or Refractory Multiple Myeloma
Primary Objective: To evaluate the pharmacokinetics (PK) of isatuximab. Secondary Objectives: To evaluate the safety and tolerability of isatuximab. To assess the preliminary antitumor effect of isatuximab.
- Trial name
- NCT03733717
- Testing
- Isatuximab SAR650984
- Where
- 3 sites in China
- Volunteers
- 25 people
- Sponsor
- Sanofi
Healthy
A Multiple Dose Study of LY2541546 in Healthy Postmenopausal Women
The purpose of this study is to assess the safety and side effects of multiple doses of LY2541546 in postmenopausal women when given subcutaneously (injection just under the skin) and intravenously (directly into a vein).
- Trial name
- NCT01742091
- Testing
- LY2541546 - SC, LY2541546 - IV
- Where
- 5 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278…
- Trial name
- NCT01656018
- Testing
- TMC278, Long acting (LA)
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Lupus Erythematosus, Systemic
BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)
The main objective of this study is to assess the safety, tolerability and pharmacokinetics of orally administered BI 705564 in patients with systemic lupus erythematosus
- Trial name
- NCT03771885
- Testing
- BI 705564
- Sponsor
- Boehringer Ingelheim
Ovarian Neoplasms, Neoplasms
Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment…
- Conditions
- Ovarian Neoplasms, Neoplasms, Solid Tumor, Hepatic Impairment
- Trial name
- NCT03359850
- Testing
- Niraparib
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Tesaro, Inc.
Breast Cancer
A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer
This two-part study is composed of two stages: a Phase Ib stage consisting of a dose-escalation phase and an expansion phase; and a Phase II, randomized, placebo-controlled, double-blind, multicenter stage.
- Trial name
- NCT04298918
- Testing
- Venetoclax, Trastuzumab emtansine
- Where
- 3 sites in Australia, South Korea
- Volunteers
- 1 people
- Sponsor
- Hoffmann-La Roche
Obesity
A Research Study on How NNC0487-0111 Works in People With Overweight or Obesity
NNC0487-0111 is a new medicine similar to 2 hormones that are produced in human body: amylin and glucagon-like peptide-1 (GLP-1). Both hormones work like body's own hormones and help the body to feel full.
- Trial name
- NCT05369390
- Testing
- NNC0487-0111 A, NNC0487-0111 B
- Where
- 2 sites in United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Autism Spectrum Disorder
Cariprazine Pediatric ASD PK Study
This study will be a multi-center, open-label, parallel-group, multiple-dose study in up to 24 male and female participants aged 5 through 17 years, inclusive, with Autism Spectrum Disorder (ASD).
- Trial name
- NCT04382885
- Testing
- Cariprazine
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- AbbVie
Gastric/Gastroesophageal Junction Cancer, Breast Cancer
A Clinical Trail of KJ015 in Patients With HER2-Expressing Solid Tumors
This is an open-label, multicenter, Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of KJ015 administered subcutaneously in participants with HER2-expressing solid tumors.
- Conditions
- Gastric/Gastroesophageal Junction Cancer, Breast Cancer, Colorectal Cancer, Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT07036185
- Testing
- KJ015 Injection (Subcutaneous Injection)
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Shanghai Bao Pharmaceuticals Co., Ltd.
Primary Immune Deficiency
Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency
The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).
- Trial name
- NCT04565015
- Testing
- GC5107
- Where
- 8 sites in United States, Bosnia and Herzegovina and 1 more
- Volunteers
- 24 people
- Sponsor
- GC Biopharma Corp
Melanoma, Non-small Cell Lung Cancer
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
A Study to Investigate Safety of AZD6750 in Adult Participants With Select Advanced or Metastatic Solid Tumors
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Squamous Cell Carcinoma (Skin), Renal Cell Carcinoma
- Trial name
- NCT07115043
- Testing
- AZD6750, rilvegostomig
- Where
- 13 sites in United States, Australia and 2 more
- Volunteers
- 120 people
- Sponsor
- AstraZeneca
Healthy
AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects
- Trial name
- JSAD/JMAD (NCT00785915)
- Testing
- AZD6765
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Schizophrenia
A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.
- Trial name
- NCT01429740
- Testing
- PF-05180999
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Pfizer
Moderate to Severe Atopic Dermatitis
Pharmacodynamic Blood Characteristics of ICP-332 in Patients With Moderate to Severe Atopic Dermatitis
The investigator, the subject, and the sponsor's project team will remain blind throughout the study. Subjects will be randomly assigned to one of the three treatment groups at a ratio of 1:1:1 to be given the drug once a day for…
- Trial name
- NCT05702268
- Testing
- ICP-332
- Where
- 28 sites in China
- Volunteers
- 75 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Advanced Solid Tumors
Phase I Study of Intravenous Lipotecan® (TLC388 HCl for Injection) in Patients With Advanced Solid Tumors
The purpose of this study is to find a safe and tolerable dose of Lipotecan® when administered to patients with advanced solid tumors.
- Trial name
- NCT00747474
- Testing
- Lipotecan
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 54 people
- Sponsor
- Taiwan Liposome Company
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Tuberculosis
Phase 1 Study of PBTZ169
Open-label prospective non-comparative safety, tolerability and pharmacokinetics ascending dose randomized cohort study of PBTZ169 (capsules 40 mg) in fasted healthy volunteers after single and multiple oral administration
- Trial name
- NCT03036163
- Testing
- PBTZ169 - 40 mg, PBTZ169 - 80 mg, PBTZ169 - 160 mg
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Nearmedic Plus LLC
Schizophrenia
Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia
To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered subcutaneously or intramuscularly in adults with schizophrenia.
- Trial name
- NCT02968121
- Testing
- Brexpiprazole, OPDC-34712
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
The first 1,020 results can be paged through. Add a filter or change the sort order to reach the rest.