Clinical trials: Pharmacokinetics
Non-Small Cell Lung Cancer
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the…
- Trial name
- NCT07079475
- Testing
- DZD6008, Sunvozertinib, Osimertinib
- Where
- 14 sites in China
- Volunteers
- 220 people
- Sponsor
- Dizal Pharmaceuticals
Type 2 Diabetes Mellitus (T2DM)
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
- Trial name
- NCT05761301
- Testing
- ALN-KHK
- Where
- 15 sites in United States, Canada
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Healthy
Safety, Pharmacokinetics, and Pharmacodynamics of SD-101 in Healthy Normal Males
The main purpose of this study is to assess the safety, tolerability, and biological activity of SD-101 compared with placebo in healthy male volunteers.
- Trial name
- NCT00599001
- Testing
- SD-101
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Healthy
A Study to Evaluate the Effect of Cholestyramine on LOXO-783 in Healthy Participants
The main purpose of this study is to conduct blood tests to measure how much LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered alone or in combination with cholestyramine in healthy…
- Trial name
- NCT05894928
- Testing
- LOXO-783, Cholestyramine
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
TTR-mediated Amyloidosis
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
- Trial name
- NCT01617967
- Testing
- Patisiran
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 29 people
- Sponsor
- Alnylam Pharmaceuticals
Healthy Volunteers
A Food-Effect Study of AND017 in Healthy Participants
The purpose of this phase I study is to evaluate the food effect on the PKs of AND017 following oral single-dose administration in healthy non-elderly Chinese subjects.
- Trial name
- NCT04712500
- Testing
- AND017
- Where
- China
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Kind Pharmaceuticals LLC
Non Hematologic Cancers
Phase I Dose Escalation Study of VS-6063 in Japanese Subjects With Non-Hematologic Malignancies
This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies.
- Trial name
- NCT01943292
- Testing
- Defactinib
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Verastem, Inc.
Healthy Volunteers
Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses…
- Trial name
- NCT07787611
- Testing
- MWN109 tablet
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
SCLC, NEC
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
- Trial name
- NCT07416695
- Testing
- HLX3901
- Where
- 2 sites in China
- Volunteers
- 138 people
- Sponsor
- Shanghai Henlius Biotech
Atrial Fibrillation
Safety Study of Tecadenoson to Treat Atrial Fibrillation
Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to control rapid heart rate.
- Trial name
- NCT00713401
- Testing
- Tecadenoson, Esmolol
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Gilead Sciences
Major Depressive Disorder, Recurrent, Unspecified
Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
Objectives To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in healthy subjects. To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.
- Trial name
- NCT02271412
- Testing
- LY03005
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy Volunteers
A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers
This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.
- Trial name
- NCT02873767
- Testing
- PR1, PL1
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Cough
The Safety, Tolerability, PK and PD of GSK2339345 in Healthy Subjects
This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The study is split into two parts. Part A will assess the safety and tolerability of the new drug.
- Trial name
- FTIH (NCT01494636)
- Testing
- GSK2339345 (solution), GSK2339345 (nebulised), Lidocaine
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus, Diabetes
Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of REMD-477 in Subjects With Type 2 Diabetes Mellitus
This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2 diabetic subjects.
- Trial name
- NCT02455011
- Testing
- REMD-477
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- REMD Biotherapeutics, Inc.
Schizophrenia, Schizoaffective Disorder
A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder
The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with…
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders
- Trial name
- NCT00796081
- Testing
- ER OROS paliperidone, paliperidone ER
- Volunteers
- 25 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
To Evaluate the PK, PD, Safety and Drug Tolerance in Healthy Volunteers
1. To evaluate the pharmacokinetic and pharmacodynamics characteristics after administration of Reference Drug or Test Drug in healthy volunteers under fasting conditions 2.
- Trial name
- NCT05433844
- Testing
- Reference Drug or Test Drug
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- JW Pharmaceutical
Rheumatoid Arthritis
An Open-label Study of CND261 in Seropositive Rheumatoid Arthritis
The purpose of the study is to evaluate the safety and efficacy of CND261 in patients with seropositive rheumatoid arthritis.
- Trial name
- NCT07052032
- Testing
- CND261
- Where
- 2 sites in Moldova, Ukraine
- Volunteers
- 47 people
- Sponsor
- Candid Therapeutics
Melanoma, Non Small Cell Lung Cancer
Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors
AI-061 is a co-formulation drug product (DP) consisting of 1:1 ratio mix of AI-025, an anti-PD-1 antibody, and ONC-392, an anti-CTLA-4 antibody.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, High Grade Serous Adenocarcinoma of Ovary
- Trial name
- PRESERVE-009 (NCT05858736)
- Testing
- AI-061
- Where
- 5 sites in Australia
- Volunteers
- 18 people
- Sponsor
- OncoC4, Inc.
Chronic Hepatitis C
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24…
- Trial name
- NCT01359644
- Testing
- PSI-7977, Daclatasvir, Ribavirin
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- Bristol-Myers Squibb
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)
This open-label Phase 1 study will evaluate the safety, PK, and antitumor activity of modified T cells (JCAR017) administered to adult patients with relapsed or refractory B-cell NHL.
- Conditions
- Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle-cell Lymphoma
- Trial name
- NCT02631044
- Testing
- JCAR017 (lisocabtagene maraleucel) single-dose schedule, JCAR017 (lisocabtagene maraleucel) 2-dose schedule
- Where
- 14 sites in United States
- Volunteers
- 387 people
- Sponsor
- Juno Therapeutics, a Subsidiary of Celgene
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