Clinical trials: Safety and Pharmacokinetics
Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
- Trial name
- NCT04091061
- Testing
- PF-06865571 100 mg
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infection, Human Immunodeficiency Virus
GSK706769 Repeat Dose Study
To determine safety, tolerability and Pharmacokinetics of GSK706769
- Trial name
- NCT00711386
- Testing
- GSK706769
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-Hodgkin's Lymphoma
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199
This is an open-label multicenter, study to assess the pharmacokinetic interaction of ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's lymphoma.
- Trial name
- NCT01969669
- Testing
- ABT-199, Ketoconazole
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- AbbVie
HIV Infections
A Clinical Study of the HIV Drug CPT31 in Healthy Volunteers
This first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of the HIV entry inhibitor CPT31 (cholesterol-PIE12-2-trimer) in healthy adults.
- Trial name
- NCT04672083
- Testing
- CPT31
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Navigen, Inc.
Multiple Myeloma
A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.
- Trial name
- NCT07090954
- Testing
- GR1803 injection, Anti-CD38 Monoclonal Antibody
- Where
- 2 sites in China
- Volunteers
- 32 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Healthy Participants
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies…
- Trial name
- NCT05720494
- Testing
- JZP441
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Primary Sjögren's Syndrome (pSS)
JH013 Injection in Patients With Primary Sjögren's Syndrome
This is a multicenter, open-label, single-arm Phase I study consisting of two parts: Part A, a single-dose dose-escalation phase, and Part B, a multiple-dose dose-escalation phase.
- Trial name
- NCT07818694
- Testing
- JH013 injection
- Volunteers
- 54 people
- Sponsor
- Biotech Pharmaceutical Co., Ltd.
Mucopolysaccharidosis VI
A Study in MPS VI to Assess Safety and Efficacy of Odiparcil
Mucopolysaccharidoses (MPS) are a group of rare inherited disorders characterized by a deficiency of lysosomal enzymes responsible for the normal degradation of glycosaminoglycans (GAGs).
- Trial name
- iMProveS (NCT03370653)
- Testing
- Odiparcil
- Where
- 4 sites in France, Germany and 2 more
- Volunteers
- 20 people
- Sponsor
- Inventiva Pharma
Safety, Pharmacokinetics
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594
The purpose of this study is to evaluate the safety profile and look at levels of AZD7594 and biomarkers in blood when the drug is administered inhaled to healthy subjects
- Conditions
- Safety, Pharmacokinetics, Pharmacodynamics of AZD7594
- Trial name
- NCT01636024
- Testing
- AZD7594
- Where
- United Kingdom
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Solid Tumor
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid…
- Trial name
- NCT05907980
- Testing
- ROSE12, Atezolizumab, Pembrolizumab
- Where
- 14 sites in United States, Japan
- Volunteers
- 209 people
- Sponsor
- Chugai Pharmaceutical
Effect of Drugs, Safety Issues
PK-PD Comparative Study of Lansoprazole Capsules and Lansoprazole Enteric-coated Capsules in Healthy Chinese Volunteers
The objective of this study was to compare the relative PK-PD of Lansoprazole Capsules and Lansoprazole DR Capsules in healthy Chinese volunteers.
- Trial name
- NCT03488186
- Testing
- Lansoprazole Capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Healthy Volunteers, Psoriasis
A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis
To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).
- Trial name
- NCT03493269
- Testing
- BAY1834845, Midazolam
- Where
- 2 sites in Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Bayer
Tetanus
Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection
A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus…
- Trial name
- NCT07149454
- Testing
- Recombinant Human Anti-Tetanus Toxin Monoclonal Antibody Injection, Human Tetanus Immunoglobulin
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
Advanced Solid Tumours
Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer
The purpose of this study is to determine whether AZD0156 is safe, what is the best dose to give, and how it is processed by the body when given alone or in combination with other agents.
- Trial name
- AToM (NCT02588105)
- Testing
- AZD0156, Olaparib, irinotecan
- Where
- 5 sites in United States, South Korea and 2 more
- Volunteers
- 84 people
- Sponsor
- AstraZeneca
Healthy
A Study to Evaluate the Safety of K-755 in Healthy Volunteers
This is a Phase 1 study designed to explore the safety, tolerability and pharmacokinetics of K-755 following oral administration to healthy male and female volunteers.
- Trial name
- NCT03414294
- Testing
- K-755 Part A (SAD), K-755 Part B (MAD), K-755 Part C (FE)
- Where
- Australia
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Kowa Company, Ltd.
Advanced Malignancies
Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies
Part 2 Cohorts A and C This study is being conducted to test the safety and pharmacokinetics of cemiplimab in patients with lung cancer.
- Trial name
- NCT03233139
- Testing
- Cemiplimab, Ipilimumab, Platinum-doublet chemotherapy
- Where
- 20 sites in Japan
- Volunteers
- 146 people
- Sponsor
- Regeneron Pharmaceuticals
Moderate-to-severe Inflammatory Bowel Disease
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with…
- Trial name
- NCT07758101
- Testing
- SHR-7590
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Hepatic Impairment
Pharmacokinetics, Safety & Tolerability of ZD4054 (Zibotentan) in Subjects With Normal, Mild, Moderate and Severe Hepatic Impairment
This study is designed to compare how ZD4054 (Zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subjects of a similar age, sex and…
- Trial name
- NCT00672581
- Testing
- ZD4054
- Where
- Czechia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Chinese Volunteers
Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.
- Trial name
- NCT01720212
- Testing
- YM178
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma China, Inc.
Healthy
A Safety, Tolerability and Pharmacokinetics Study of JNJ-54861911 in Healthy Japanese Male Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK, study of the way a drug enters and leaves the blood and tissues over time) of single-ascending oral doses of JNJ-54861911 in healthy…
- Trial name
- NCT02180269
- Testing
- JNJ-54861911 (25 mg), JNJ-54861911 (50 mg), JNJ-54861911 (100 mg)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
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