Clinical trials: Single Women
Renal Insufficiency, Acute, Renal Insufficiency, Chronic
Evaluate Safety and Pharmacokinetics of Minocin (Minocycline) for Injection in Subjects With Renal Insufficiency
This is a Phase 1, open-label, single-dose study of the safety, tolerability, and pharmacokinetics of Minocin® (minocycline) for injection in subjects with renal insufficiency.
- Conditions
- Renal Insufficiency, Acute, Renal Insufficiency, Chronic, Healthy Subjects
- Trial name
- NCT02808052
- Testing
- Minocin (minocycline) for Injection
- Where
- Germany
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)
Breast Cancer, Healthy Volunteers
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
Primary Objectives: To assess the excretion balance after oral and IV administration of [14C]-SAR439859 To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV administration of [14C]-SAR439859 and…
- Trial name
- NCT04940026
- Testing
- amcenestrant, [14C]-SAR439859 microtracer, [14C]-SAR439859
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Breast Cancer
Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)
The purpose of this study is to preliminarily determine the correlation of HER2 receptor levels detected with the inPROBE diagnostic probe relative to receptor status as determined by standard methods (IHC/FISH), in women with…
- Trial name
- NCT05415943
- Testing
- Diagnostic microprobe (inPROBE) medical device
- Where
- 2 sites in Poland
- Volunteers
- 18 people
- Sponsor
- SDS Optic S.A.
Safety Issues
Oral Remimazolam With and Without Alcohol in Healthy Female Subjects
A Phase 1 Study to Determine the Single-dose Pharmacodynamics, Pharmacokinetics, and Safety and Tolerability of Remimazolam Following Oral Administration With and Without Alcohol in Healthy Female Subjects
- Trial name
- NCT04113343
- Testing
- Remimazolam, Alcohol
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Chronic Kidney Diseases
Safety and Efficacy of KDSTEM Inj. in Patients With Chronic Kidney Disease
A Single arm, Open-labelled, Dose-escalation, Single-center, Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Autologous Urine-derived Stem Cells, 『KDSTEM Inj.』, in Patients with Chronic Kidney…
- Trial name
- NCT06071143
- Testing
- KDSTEM Inj.
- Where
- South Korea
- Volunteers
- 6 people
- Sponsor
- EHL Bio Co., Ltd.
Neoplasms, Breast Neoplasms
Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer
The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone.
- Conditions
- Neoplasms, Breast Neoplasms, Breast Cancer
- Trial name
- MINT (NCT01151215)
- Testing
- AZD8931, anastrozole
- Where
- 60 sites in United States, Brazil and 16 more
- Volunteers
- 482 people
- Sponsor
- AstraZeneca
Pharmacokinetics
An Open-label, Single-dose, Three Period Study to Determine the Pharmacokinetic Parameters of Hexaminolevulinate (HAL) Hydrochloride After Vaginal, Enema and Intravenous Administration of Healthy Female Volunteers
The study will determine the extent of systemic absorption of HAL following vaginal and enema administration compared to intravenous administration to healthy female volunteers.
- Trial name
- NCT01050309
- Testing
- hexaminolevulinate (HAL)
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Photocure
Renal Impairment, Healthy Volunteers
A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on the PK of single IV doses of…
- Trial name
- NCT03296787
- Testing
- TAK-954
- Where
- 4 sites in Czechia, Hungary
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Takeda
Postmenopausal Osteoporosis
Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
- Trial name
- NCT04366726
- Testing
- abaloparatide-sMTS
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Radius Health, Inc.
Ovarian Neoplasms, Fallopian Tube Neoplasms
DNA Single Nucleotide Polymorphisms as Predictors of Toxicity
The presence of single nucleotide polymorphisms (SNPs) in genes involved in platinum and taxane metabolism and detoxification have been correlated to increased risk of severe adverse events (AEs) when patients receive these…
- Conditions
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- Trial name
- NCT02478476
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- OvaGene Oncology, Inc.
Renal Insufficiency, Hepatic Insufficiency
Study to Evaluate the Effects of Underlying Renal or Hepatic Dysfunction on the Pharmacokinetics of Nevirapine
Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing…
- Trial name
- NCT02184091
- Testing
- Nevirapine
- Volunteers
- 41 people
- Sponsor
- Boehringer Ingelheim
Healthy
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions
The purpose of this study is to compare bioavailability in healthy, post menopausal women subjects under fed conditions.
- Trial name
- NCT01155960
- Testing
- Anastrozole
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Osteoarthritis, Pain
Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee
The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee.
- Trial name
- NCT01072591
- Testing
- MEDI-578
- Where
- United Kingdom
- Volunteers
- 108 people
- Sponsor
- AstraZeneca
Healthy Participants
Phase 1 Single and Multiple Ascending Dose of LTG-321 in Healthy Participants
This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics…
- Trial name
- NCT07110610
- Testing
- LTG-321
- Where
- New Zealand
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Latigo Biotherapeutics
End Stage Renal Disease
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with renal impairment and healthy subjects conducted at approximately 2 sites in the United States.
- Trial name
- NCT02135276
- Testing
- eravacycline
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Tetraphase Pharmaceuticals, Inc
IgA Nephropathy (IgAN)
IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy
Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study
- Trial name
- NCT07886476
- Testing
- IBI3034, Telitacicept
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Facet Joint Pain
ITX24-01 in Adult Male and Female Patients With Select Types of Severe Chronic Neck- and Lower Back Pain
The study is a single ascending dose (SAD), single-center, randomised, double-blind, placebo-controlled Phase 1b clinical trial designed to evaluate the safety, tolerability, and preliminary analgesic efficacy of ITX24-01 in…
- Trial name
- NCT07520240
- Testing
- ITX24-01, Normal Saline (0.9% NaCl)
- Where
- Australia
- Volunteers
- 32 people
- Sponsor
- Interventional AnalgesiX Inc.
Kidney Disease, Chronic Kidney Disease
Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease (CKD) Receiving Dialysis
The proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis.
- Trial name
- NCT00096915
- Testing
- Darbepoetin Alfa
- Volunteers
- 110 people
- Sponsor
- Amgen
Renal Insufficiency, Healthy
A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.
The main purpose of this study is to assess the amount of study drug (LY3502970) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared…
- Trial name
- NCT05936138
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Drug Induced Constipation
Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118
Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics of NKTR-118
- Trial name
- NCT01533155
- Testing
- Nektar 118, Quinidine, Morphine
- Where
- United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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