Clinical trials: Oral Complications
Renal Impairment, Renal Insufficiency
Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients
This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment.
- Conditions
- Renal Impairment, Renal Insufficiency, Kidney Diseases, Pharmacokinetics
- Trial name
- NCT03844555
- Testing
- Elafibranor
- Where
- 2 sites in France, Romania
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Genfit
Chronic Kidney Disease, Anemia
Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis
The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to…
- Trial name
- NCT00761657
- Testing
- Roxadustat
- Where
- 34 sites in United States
- Volunteers
- 117 people
- Sponsor
- Kyntra Bio
Diabetic Foot
BE STUDY OF METFORMIN GSK 1000mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition.
- Trial name
- BA/BE 199/11 (NCT01710553)
- Testing
- Glucophage 1000mg, Metformin GSK 1000mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Esophageal Cancer, Gastric Cancer
Oral Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702 in Combination With Pembrolizumab in Patients With Selected Advanced Solid Tumors
This study is a phase 1B/2 open-label, study to determine safety and preliminary efficacy of Q702 in combination with pembrolizumab in study subjects with advanced esophageal, gastric/GEJ, hepatocellular, and cervical cancers.
- Conditions
- Esophageal Cancer, Gastric Cancer, Hepatocellular Cancer, Cervical Cancer
- Trial name
- NCT05438420
- Testing
- Q702, Pembrolizumab
- Where
- 7 sites in United States, South Korea
- Volunteers
- 120 people
- Sponsor
- Qurient Co., Ltd.
Healthy Volunteers, Chronic Kidney Disease
A Study to See How Safe a New Medicine (NNC0705-0001) is in Healthy People
The study is testing a new study medicine (called NNC0705-0001), as a potential medicine to treat chronic systemic inflammation, which is known for increasing the risk of developing cardiometabolic diseases.
- Trial name
- NCT07029568
- Testing
- NNC0705-0001
- Where
- Netherlands
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
ccRCC, Clear Cell Renal Cell Carcinoma
A Study of NKT2152, a HIF2α Inhibitor, in Patients With Advanced Clear Cell Renal Cell Carcinoma
The goal of the Phase 1 portion is to identify the maximum tolerated dose (MTD) and/or the recommended doses for expansion (RDEs) of NKT2152. The Phase 2 portion will evaluate the efficacy of NKT2152 in ccRCC.
- Conditions
- ccRCC, Clear Cell Renal Cell Carcinoma, Kidney Cancer, Kidney Neoplasms
- Trial name
- NCT05119335
- Testing
- Oral NKT2152
- Where
- 13 sites in United States
- Volunteers
- 120 people
- Sponsor
- NiKang Therapeutics, Inc.
Diabetic Neuropathies, Diabetes Mellitus
Phase I Study of BM2216 ER vs. Melogabalin Besilate: Safety, PK, and Food Effect in Healthy Adults
A Phase I Clinical Study Evaluating the Safety, Pharmacokinetics, Food Effect, Single-Dose Proportionality, and Multiple-Dose Pharmacokinetic Comparison with Melogabalin Besilate Tablets after Single and Multiple Oral…
- Trial name
- NCT06846567
- Testing
- BM2216 Extended-Release tablets（5.5mg）, Mirogabalin Besilate Tablets, BM2216 Extended-Release Tablets(11mg)
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Zhejiang Anglikang Pharmaceutical Co., Ltd.
Pelvic Inflammatory Disease
First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY1834845
This study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of BAY1834845 using a placebo controlled, randomized, single…
- Trial name
- NCT03054402
- Testing
- BAY1834845
- Where
- Germany
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bayer
Polycystic Ovary Syndrome
Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116
This study will be conducted in a single center, double-blind with 6 dose escalation groups to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of BAY1161116.
- Trial name
- NCT03119077
- Testing
- BAY1161116, Itraconazole
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bayer
Surgical Site Infection
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
The purpose of this study is to assess the efficacy and safety of delafloxacin administered as IV and oral formulation in comparison with Best Available Therapy (BAT) in patients with superficial or deep incisional surgical site…
- Trial name
- DRESS (NCT04042077)
- Testing
- Delafloxacin, Vancomycin, Linezolid
- Where
- Italy
- Volunteers
- 268 people
- Sponsor
- Menarini Group
Renal Impairment
Assessing the Pharmacokinetics of NKTR-118 in Subjects With Renal Impairment Compared to That in Subjects With Normal Renal Function
This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
- Trial name
- NCT01372826
- Testing
- NKTR118 Group1, NKTR118 Group 2, NKTR118 Group3
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Type 2 Diabetes Mellitus (T2DM)
Phase III Trial of SGLT2 Inhibitor and Thiazolidinedione Fixed-Dose Combination vs. Monotherapy in Type 2 Diabetes Patients on Metformin
This clinical trial is studying whether combining two commonly used diabetes medications into a single pill works better than taking them separately for people with type 2 diabetes who are already on metformin.
- Trial name
- CONTROL (NCT07057479)
- Testing
- Fixed-dose combination of SGLT2 inhibitor and thiazolidinedione, Control Group 1 Intervention - SGLT2 inhibitor monotherapy, Control Group 2 Intervention - Thiazolidinedione monotherapy
- Where
- Brazil
- Sponsor
- Eurofarma Laboratorios S.A.
Prostate Cancer Metastatic
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
This first-in-human, Phase 1/2, open-label study evaluates the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of JSB462 (luxdegalutamide, previously ARV-766) administered as monotherapy and in…
- Trial name
- NCT05067140
- Testing
- ARV-766, Abiraterone, Corticosteroid (e.g., prednisone/prednisolone)
- Where
- 17 sites in United States
- Volunteers
- 164 people
- Sponsor
- Novartis Pharmaceuticals
Parkinson Disease
Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced…
- Trial name
- AMBLED (NCT03162874)
- Testing
- PXT002331 - dose 1, PXT002331 - dose 2
- Where
- 45 sites in Austria, France and 4 more
- Volunteers
- 157 people
- Sponsor
- Prexton Therapeutics
Carcinoma, Renal Cell
Part A: Radiolabel Study With GW786034 Part B: Single Dose of GW786034
To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034
- Trial name
- NCT00478725
- Testing
- GW786034, oral, GW786034, IV, GW786034, radiolabeled oral
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- GlaxoSmithKline
Recurrent Vulvovaginal Candidiasis
A Study of Oral Oteseconazole for the Treatment of Patients With Recurrent Vaginal Candidiasis (Yeast Infection)
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months.
- Trial name
- VIOLET (NCT03562156)
- Testing
- Oteseconazole (VT-1161)
- Where
- 25 sites in United States
- Volunteers
- 438 people
- Sponsor
- Mycovia Pharmaceuticals Inc.
Hyponatremias, Water Intoxication
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.
- Conditions
- Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
- Trial name
- NCT00072683
- Testing
- tolvaptan
- Where
- 23 sites in United States
- Volunteers
- 205 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Renal Insufficiency, Healthy
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems
This study is open to adults aged 18 years and older. People without kidney problems and people who have moderate or severe kidney problems can join the study.
- Trial name
- NCT05718648
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Uterine Fibroids, Heavy Menstrual Bleeding
Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.
The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in…
- Trial name
- NCT05620355
- Testing
- BG2109, Add-back therapy
- Where
- 29 sites in China
- Volunteers
- 312 people
- Sponsor
- Bio Genuine (Shanghai) Biotech Co., Ltd.
Bacterial Vaginosis
Treatment of Bacterial Vaginosis With Oral Tinidazole
The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.
- Trial name
- NCT00229216
- Testing
- Tinidazole
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Mission Pharmacal