Clinical trials: Estrogen Receptor Negative
Attention Deficit Hyperactivity Disorder, ADHD
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention…
- Trial name
- NCT01239030
- Testing
- Methylphenidate Hydrochloride Extended Release Capsules
- Where
- 16 sites in United States
- Volunteers
- 230 people
- Sponsor
- Rhodes Pharmaceuticals, L.P.
ER+ HER2- Advanced Breast Cancer
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to…
- Trial name
- NCT04541433
- Testing
- AZD9833
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or…
- Trial name
- MoonROSE (NCT07100106)
- Testing
- GDC-4198, Giredestrant, Abemaciclib
- Where
- 77 sites in United States, Australia and 8 more
- Volunteers
- 285 people
- Sponsor
- Genentech, Inc.
Healthy
Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioequivalence of Naproxen sodium 220 mg + Pseudoephedrine Hydrochloride 120 mg Extended Release tablets of with Aleve Cold and Sinus in healthy adult human subjects, under fasting…
- Trial name
- NCT01131728
- Testing
- Naproxen Sodium & Pseudoephedrine HCl
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Solid Tumors, ER+ Breast Cancer
JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
This study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
- Conditions
- Solid Tumors, ER+ Breast Cancer, Triple Negative Breast Cancer, TNBC, ARID1A Gene Mutation
- Trial name
- NCT05490472
- Testing
- JAB-2485 (Aurora A inhibitor)
- Where
- 8 sites in United States, China
- Volunteers
- 102 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
Schizophrenia
A Study of the Bioequivalence of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville
The purpose of this study is to establish bioequivalence of paliperidone ER tablets manufactured at Gurabo as compared to paliperidone ER tablets manufactured at Vacaville, administered as a single dose of 12 mg under fasted…
- Trial name
- NCT00790777
- Testing
- Paliperidone ER
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Severe Renal Impairment
A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well as Safety/Tolerability, of Ranolazine
The purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with normal renal function.
- Trial name
- NCT01675973
- Testing
- RANEXA
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Early Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk…
- Trial name
- NCT04961996
- Testing
- Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
- Where
- 621 sites in United States, Argentina and 52 more
- Volunteers
- 4,170 people
- Sponsor
- Hoffmann-La Roche
Healthy
A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy…
- Trial name
- NCT04230252
- Testing
- Acetaminophen
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Janssen Korea, Ltd., Korea
Advanced Breast Cancer
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on…
- Trial name
- BOLERO-5 (NCT03312738)
- Testing
- Everolimus, Exemestane
- Where
- 15 sites in China
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
Schizophrenia
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.
- Trial name
- NCT00524043
- Testing
- Paliperidone ER
- Where
- 20 sites in United States, India and 1 more
- Volunteers
- 201 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Advanced or Metastatic ER+ Breast Cancer
Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with…
- Trial name
- NCT02734615
- Testing
- LSZ102, LEE011, BYL719
- Where
- 10 sites in United States, Belgium and 5 more
- Volunteers
- 199 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Subjects
Mucinex® ER 600 mg Bi-Layer Tablet Fed and Fasted
Determine and compare the plasma concentrations of Mucinex® Extended Release (ER) 600 mg bi-layer tablet in normal healthy volunteers in fed and fasting conditions
- Trial name
- NCT03649750
- Testing
- Mucinex®
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser LLC
Healthy Subjects
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.
- Trial name
- NCT05551897
- Testing
- Camizestrant, Itraconazole
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca