Clinical trials: Drug Kinetics
Hemophilia B
Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients
This study is a phase 1, open-label, multi-center, dose-escalation study to investigate the safety, pharmacokinetics and pharmacodynamics of ISU304/CB2679d in previously treated hemophilia B patients.
- Trial name
- NCT03186677
- Testing
- ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg, BeneFIX
- Where
- 3 sites in South Korea
- Volunteers
- 11 people
- Sponsor
- ISU Abxis Co., Ltd.
Coronavirus
COVID-19 First In Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of EIDD-2801 in Healthy Volunteers
This is a First In Human study designed to assess the safety, tolerability and pharmacokinetics of EIDD-2801 in healthy human volunteers.
- Trial name
- NCT04392219
- Testing
- EIDD-2801
- Where
- United Kingdom
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Ridgeback Biotherapeutics, LP
Pain
CSF Pharmacokinetics of Ondansetron
Serotonergic 5-HT3 receptors in the central nervous system are involved in pain processing after nerve injury. We are interested in learning if 5-HT3 receptor antagonist ondansetron might be an appropriate drug for treating pain…
- Trial name
- NCT02901054
- Testing
- Ondansetron
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Washington University School of Medicine
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.
Lymphoma, Follicular
To Demonstrate Equivalence of Pharmacokinetics and Noninferiority of Efficacy for CT-P10 in Comparison With Rituxan
This study is a Phase 3 prospective, randomised, parallel-group, active controlled, double blind, multicentre, international study with 2 coprimary endpoints designed to demonstrate equivalence in pharmacokinetics (Part 1), as…
- Trial name
- rituximab (NCT02162771)
- Testing
- Rituxan, CT-P10, Cyclophosphamide
- Volunteers
- 140 people
- Sponsor
- Celltrion
Gaucher Disease
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease to Evaluate Once Daily Versus Twice Daily Dosing (EDGE)
The primary objective of this study was to evaluate the efficacy and safety of once daily (QD) versus twice daily (BID) dosing of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had demonstrated…
- Trial name
- NCT01074944
- Testing
- Eliglustat tartrate
- Where
- 46 sites in United States, Australia and 15 more
- Volunteers
- 170 people
- Sponsor
- Genzyme, a Sanofi Company
Neoplasms
BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of safety, tolerability and preliminary therapeutic effects of [14C]volasertib in patients with advanced solid tumours.
- Trial name
- NCT01145885
- Testing
- BI 6727
- Where
- Hungary
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
Plasma Cell Myeloma
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Primary Objectives: To evaluate the safety and tolerability of the combination of isatuximab (also known as SAR650984) and cemiplimab (also known as REGN2810) in patients with relapse/refractory multiple myeloma.
- Trial name
- NCT03194867
- Testing
- Isatuximab SAR650984, Cemiplimab REGN2810
- Where
- 30 sites in United States, Australia and 8 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Alzheimer's Disease
A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)
This is a randomized, double-blind, placebo-controlled first-in-human, Phase 1, safety, tolerability, pharmacokinetic (PK) and preliminary exploratory activity study of escalating multiple intravenous (IV) doses of IBC-Ab002 in…
- Trial name
- NCT05551741
- Testing
- IBC-Ab002
- Where
- 10 sites in Israel, Netherlands and 1 more
- Volunteers
- 40 people
- Sponsor
- Immunobrain Checkpoint
Narcolepsy Type 1 (NT 1)
A Study of TAK-994 in Adults With Narcolepsy
Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in this study. The main aim of this study is to check if participants have side effects from TAK-994.
- Trial name
- NCT04820842
- Testing
- TAK-994
- Where
- 70 sites in United States, Canada and 8 more
- Volunteers
- 26 people
- Sponsor
- Takeda
Ulcerative Colitis
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.
- Trial name
- NCT01130844
- Testing
- MMX Mesalamine
- Where
- 19 sites in United States, Australia and 3 more
- Volunteers
- 52 people
- Sponsor
- Shire
Healthy
A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants
The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with clarithromycin in healthy participants.
- Trial name
- NCT05469126
- Testing
- LY3502970, Clarithromycin
- Where
- Singapore
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
HIV Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Dengue
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a…
- Trial name
- NCT05048875
- Testing
- Cohort 1 - Group 1 JNJ High Dose, Cohort 1 - Group 2 JNJ Medium Dose, Cohort 1 - Group 2 JNJ Low Dose
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 2 Diabetes Mellitus
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose levels in response to an oral glucose…
- Trial name
- NCT00605475
- Testing
- Canakinumab, Metformin
- Where
- 13 sites in United States, Germany and 1 more
- Volunteers
- 231 people
- Sponsor
- Novartis
Healthy Volunteers
A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.
- Trial name
- NCT02419001
- Testing
- Period 1 - Treatment Sequence AB, Period 1 - Treatment Sequence AC, Period 2 - Treatment Sequence AB
- Where
- 3 sites in United States, Canada
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Theriva Biologics, Inc.
Healthy Participants
A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants
The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.
- Trial name
- NCT03085836
- Testing
- TAK-438
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Comparative Pharmacokinetics and Food-Effect Bioavailability of Lubiprostone Sprinkle in Healthy Volunteers
A study to compare the pharmacokinetics and food-effect bioavailability of sprinkle formulation of lubiprostone, as compared to lubiprostone capsules in healthy volunteers.
- Trial name
- NCT03010631
- Testing
- Cohort 1: Lubiprostone Capsule, Fasted, Cohort 1: Lubiprostone Sprinkle Formulation, Fasted, Cohort 2: Lubiprostone Sprinkle Formulation, Fed
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Sucampo Pharma Americas, LLC
Hepatic Insufficiency
Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
The primary objective of this study is to investigate the effect of mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment on the pharmacokinetics, safety and tolerability of nintedanib, in…
- Trial name
- NCT02191865
- Testing
- Nintedanib
- Where
- Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How BI 474121 is Tolerated
Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese male using single rising oral doses in order to provide the basis for an ongoing clinical development of BI 474121 for the treatment of…
- Trial name
- NCT04964453
- Testing
- BI 474121
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim