Clinical trials: Pharmacology
Hepatic Impairment
Pharmacokinetic Study of BKM120 in Subjects With Hepatic Impairment
To assess pharamcokinetics, safety and tolerability of a single oral dose of BKM120 in subjects with mild, moderate and severe hepatic impairment
- Trial name
- NCT01727128
- Testing
- BKM120
- Where
- 3 sites in Bulgaria, Germany and 1 more
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cancer
A Study of Atezolizumab Administered in Combination With Bevacizumab and/or With Chemotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
This open-label, Phase Ib study that has six treatment arms is designed to assess the safety, pharmacology and preliminary efficacy of atezolizumab (MPDL3280A; an engineered anti-programmed death-ligand 1 [PDL1] antibody)…
- Trial name
- NCT01633970
- Testing
- 5-FU, Atezolizumab, Bevacizumab
- Where
- 11 sites in United States
- Volunteers
- 240 people
- Sponsor
- Genentech, Inc.
Healthy Volunteers, Pharmacologic Action
A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate
This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on the single-dose PK of AZD3293 and the effects…
- Trial name
- AZD3293DDI (NCT02010970)
- Testing
- Group 1 AZD3293, Group 2 AZD3293, Group 3 AZD3293
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pharmacology, Clinical
Study to Investigate ADME of 14C Labeled SLV334 After an i.v. Infusion
This study will investigate the absorption, distribution, metabolism and excretion after giving 2000 mg 14C-SLV334 via a 1-hour infusion. The absolute bioavailability will also be determined.
- Trial name
- NCT01044524
- Testing
- SLV 334
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Solvay Pharmaceuticals
Candidemia, Mycoses
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by optional oral fluconazole).
- Conditions
- Candidemia, Mycoses, Fungal Infection, Invasive Candidiases
- Trial name
- ReSTORE (NCT03667690)
- Testing
- Rezafungin for Injection, Caspofungin, Fluconazole
- Where
- 132 sites in United States, Argentina and 16 more
- Volunteers
- 199 people
- Sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Type 2 Diabetes Mellitus
A Phase 4, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 4, Open-label, Long-term Study of SYR-472 (100 mg) in Combination With Insulin in Patients With Type 2 Diabetes
The purposes of this study is to evaluate the efficacy and safety of SYR-472 when administered at a dose of 100 mg once weekly as an add-on to insulin therapy compared with placebo in patients with type 2 diabetes mellitus and…
- Trial name
- NCT02324569
- Testing
- SYR-472
- Where
- 65 sites in Japan
- Volunteers
- 240 people
- Sponsor
- Takeda
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008423
- Testing
- Budesonide
- Where
- 62 sites in United States
- Volunteers
- 281 people
- Sponsor
- Bausch Health Americas, Inc.
Infertility, In Vitro Fertilization
Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)
The primary objective of this trial was to investigate the appropriate dose of a single injection of Org 36286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol…
- Trial name
- NCT00702806
- Testing
- Org 36286, Puregon®, Orgalutran®
- Volunteers
- 99 people
- Sponsor
- Organon and Co
Clinical Pharmacology, Healthy Male Volunteer Study
Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that…
- Trial name
- NCT02049528
- Testing
- CC-122
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Celgene
Type 2 Diabetes
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
- Trial name
- NCT00147745
- Testing
- Colesevelam, Insulin glargine (Lantus)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Daiichi Sankyo
Endometriosis
Pilot Study on a Dietary Supplement With EndoGen™ as Adjunct Therapy in Women With Endometriosis
Current treatments for endometriosis, such as NSAIDs and hormone therapies, are meant for long-term use but often cause side effects, including stomach, liver, heart, and kidney issues; allergies; and hormonal problems like…
- Trial name
- NCT07228975
- Testing
- MetrioFen Gocce
- Where
- 7 sites in Italy
- Volunteers
- 36 people
- Sponsor
- Endok s.r.l.
Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP)
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
- Trial name
- NCT01808092
- Testing
- ceftazidim-avibactam (CAZ-AVI, experimental product), meropenem (active comparator)
- Where
- 123 sites in Argentina, Brazil and 24 more
- Volunteers
- 969 people
- Sponsor
- Pfizer
Renal Impairment
Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.
To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral dose in subjects with moderate and severe renal impairment.
- Trial name
- NCT02048787
- Testing
- Buparlisib
- Where
- 4 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Heartburn, Indigestion
A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants
Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time.
- Conditions
- Heartburn, Indigestion, Stomach Acid Related Symptoms, Nocturnal Stomach Acid Related Symptoms
- Trial name
- NCT06293326
- Testing
- bi-layer calcium carbonate tablet (BAY1180654), Immediate release calcium carbonate tablet (BAY1180654)
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Bayer
Proctitis, Proctosigmoiditis
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who…
- Trial name
- NCT01008410
- Testing
- Budesonide
- Where
- 63 sites in United States
- Volunteers
- 265 people
- Sponsor
- Bausch Health Americas, Inc.
Alzheimer Disease
To Evaluate Safety, Tolerability and Pharmacological Effects of PU AD in Subjects With Mild AD Dementia
The study is designed as a classic, randomized, double blind, placebo controlled, parallel group study including one active dose of PU AD and matching placebo, designed to assess safety, tolerability and pharmacological effects…
- Trial name
- NCT04311515
- Testing
- Tau Positron emission tomography (PET), Fluorodeoxyglucose (FDG) Positron emission tomography (PET), Cerebrospinal fluid (CSF) Biomarkers
- Where
- 10 sites in United States
- Volunteers
- 4 people
- Sponsor
- Samus Therapeutics, Inc.
Carcinoma, Non-Small Cell-Lung, Lung Neoplasms
A Phase 1b/2 Study in Asian Subjects With Non-Small Cell Lung Cancer
During Phase 1b portion, there will be a dose-escalation of AV-299 (formerly SCH 900105) in combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid tumor.
- Conditions
- Carcinoma, Non-Small Cell-Lung, Lung Neoplasms, Lung Cancer, Respiratory Tract Neoplasms
- Trial name
- NCT01039948
- Testing
- AV-299 + gefitinib, Gefitinib
- Where
- 26 sites in Hong Kong, Malaysia and 5 more
- Volunteers
- 203 people
- Sponsor
- AVEO Pharmaceuticals, Inc.
Osteoporosis
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets
The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in…
- Trial name
- NCT02106442
- Testing
- Sodium risedronate
- Where
- 2 sites in Japan
- Volunteers
- 579 people
- Sponsor
- Takeda
Clinical Pharmacology
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions
To evaluate the relative bioavailability of naproxen sodium/diphenhydramine hydrochloride (DHP HCL) 220/25 mg soft capsules (Test) versus naproxen sodium/DPH HCl 220/25 mg tablets (Reference) after a single oral administration (2…
- Trial name
- NCT03424135
- Testing
- Naproxen sodium and diphenhydramine hydrochloride soft capsules, Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bayer
Overactive Bladder
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment…
- Trial name
- NCT04103450
- Testing
- Vibegron
- Where
- 35 sites in United States, Poland
- Volunteers
- 276 people
- Sponsor
- Urovant Sciences GmbH