Clinical trials: Pharmacokinetics
Healthy
Influence of Bosentan on the Pharmacokinetics of Nintedanib
The trial was designed to investigate whether, and to which extent, multiple doses of bosentan may influence the plasma levels of nintedanib administered as a single dose.
- Trial name
- NCT02667704
- Testing
- Bosentan, Nintedanib
- Where
- Germany
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
TED
A Study of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease.
Multicentre, Randomized, Double-blinded, Phase I/II Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of SCTT11 in Healthy Participants and Participants with Thyroid Eye Disease
- Trial name
- NCT06769984
- Testing
- SCTT11
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Sinocelltech Ltd.
Schizophrenia
Evaluation of NBI-1117570 in Inpatient Adults With Schizophrenia
The primary objective for this study is to evaluate the efficacy of NBI-1117570 compared with placebo on improving behavioral and psychological symptoms of schizophrenia in adults who warrant inpatient hospitalization.
- Trial name
- NCT07288333
- Testing
- NBI-1117570
- Where
- 6 sites in Bulgaria, Romania and 1 more
- Volunteers
- 120 people
- Sponsor
- Neurocrine Biosciences
HIV Infections
A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants
The primary purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (PK) profiles of two different cabotegravir formulations in healthy adult participants.
- Trial name
- NCT06033547
- Testing
- Cabotegravir Formulation F, Cabotegravir Formulation G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hepatitis B
Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment
This is a Phase 1, open-label, parallel-group study to evaluate the pharmacokinetics of GSK3228836 in participants with Child-Pugh B (CP-B) cirrhosis (moderate hepatic impairment), Child-Pugh A (CP-A) cirrhosis (mild hepatic…
- Trial name
- NCT04971928
- Testing
- GSK3228836
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study of JNJ-40411813 in Healthy Japanese Male Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male participants.
- Trial name
- NCT04677530
- Testing
- JNJ-40411813
- Where
- Japan
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Healthy
Tolerability and Pharmacokinetics of Lacidipine With and Without the Co-administration of Telmisartan in Female and Male Healthy Subjects
The objectives of this study are to compare the steady state pharmacokinetics of lacidipine with and without the co-administration of telmisartan and to compare the steady state pharmacokinetics of telmisartan with and without…
- Trial name
- NCT02203500
- Testing
- Lacidipine, Telmisartan
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Renal Impairment
Evaluating Patients With Varying Degrees of Renal Function
This is a Phase I, open-label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of renal function.
- Trial name
- NCT00398307
- Testing
- S-1/Cisplatin
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Taiho Oncology, Inc.
Hypogammaglobulinemia, Bacterial Infections
A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma
The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in…
- Conditions
- Hypogammaglobulinemia, Bacterial Infections, B-cell Chronic Lymphocytic Leukemia, Multiple Myleoma
- Trial name
- EXCELL (NCT05645107)
- Testing
- Xembify
- Where
- 62 sites in United States, Bosnia and Herzegovina and 6 more
- Volunteers
- 386 people
- Sponsor
- Grifols Therapeutics LLC
Healthy Male Participants
A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants
The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.
- Trial name
- NCT06088264
- Testing
- BMS-986322
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Adult Volunteers
99mTc-rhAnnexin V-128: a First In Man Study in Healthy Volunteers
The objectives of this study are: To determine the safety and tolerability of a single dose of 99mTc-rhAnnexin V-128 administered as an intravenous bolus over 10-20 seconds.
- Trial name
- NCT02182609
- Testing
- Kit for the Preparation of 99mTc-rhAnnexin V-128
- Where
- Canada
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Advanced Accelerator Applications
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Hepatic Impairment
A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.
The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a…
- Trial name
- NCT05582187
- Testing
- Fosmanogepix
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Non-Hodgkin's Lymphoma
A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients
The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma
- Trial name
- NCT04152148
- Testing
- 500mg BAT4306F, 750mg BAT4306F, 900mg BAT4306F
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Bio-Thera Solutions
Neoplasms
A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.
This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors.
- Trial name
- NCT00773526
- Testing
- RO5126766
- Where
- 3 sites in France, Spain and 1 more
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Non-small Cell Lung Cancer
A Study to Evaluate the Tolerance, Pharmacokinetics and Efficacy of TQ-A3334 Tablets
This is a study to evaluate the tolerance, dose-limiting toxicity (DLT), and maximum tolerated dose (MTD) of single and multiple oral doses of TQ-A3334 and observe the efficacy of TQ-A3334 in combination with anlotinib capsules…
- Trial name
- NCT04273815
- Testing
- TQ-A3334, Anlotinib
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Pulmonary Arterial Hypertension
Study of ACT-293987 (NS-304) in Pulmonary Arterial Hypertension (PAH)
This is a multi-centre, multinational, open-label, single-dose acute hemodynamic study followed by randomized, double-blind, parallel-group, placebo controlled study.
- Trial name
- NCT00993408
- Testing
- ACT-293987 (NS-304)
- Where
- 8 sites in Austria, Belgium and 6 more
- Volunteers
- 43 people
- Sponsor
- Actelion
Obesity and Overweight
This Study Will Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MET097 in Adult Participants With Overweight or Obesity
The goal of this Phase 1/2 clinical trial is to assess the safety, tolerability, pharmacokinetics, and efficacy of once-weekly subcutaneous injections of MET097 in otherwise healthy adults with overweight or obesity.
- Trial name
- NCT06857617
- Testing
- (Part C) MET097
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Metsera, a wholly owned subsidiary of Pfizer
Obesity, Overweight
A Research Study on How UBT251 Affects Levels of Midazolam, Caffeine and Warfarin in the Blood of Participants With Excess Body Weight
The purpose of this clinical study is to find out if UBT251 is safe and effective to be taken together with medicines, like midazolam, caffeine and warfarin in participants living with overweight or obesity.
- Trial name
- NCT07710768
- Testing
- UBT251, Cocktail (Warfarin/Caffeine/Midazolam)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.