Clinical trials: Multiple Dose
Congenital Muscular Dystrophy
Congenital Muscular Dystrophy Ascending Multiple Dose Cohort Study Analyzing Pharmacokinetics at Three Dose Levels In Children and Adolescents With Assessment of Safety and Tolerability of Omigapil (CALLISTO)
The purpose of the study is to establish the pharmacokinetic profile of omigapil in paediatric and adolescent patients with CMD and to evaluate the safety and tolerability of omigapil. Funding source - FDA OOPD
- Trial name
- CALLISTO (NCT01805024)
- Testing
- Omigapil
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Santhera Pharmaceuticals
Prophylaxis of A/H3N2v Influenza
Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.
Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to <9 years, adolescents 9 to <18 years, adults 18 to <65 years and elderly 65 years and older.
- Trial name
- NCT01855945
- Testing
- Swine Influenza
- Where
- 11 sites in United States
- Volunteers
- 627 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Post Operative Pain
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Post Surgical Pediatric Subjects
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic for acute postoperative pain in pediatric subjects.
- Trial name
- NCT01210352
- Testing
- oxymorphone HCl
- Where
- 8 sites in United States
- Volunteers
- 61 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Abdominal Aortic Aneurysm (AAA)
ACZ885 for the Treatment of Abdominal Aortic Aneurysm
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on aneurysmal growth rate in subjects with abdominal aortic aneurysms (AAA).
- Trial name
- AAA (NCT02007252)
- Testing
- ACZ885
- Where
- 9 sites in United States, Denmark and 3 more
- Volunteers
- 65 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Efficacy and Safety Study in Subjects With Asthma
The study is a multi-center, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of selected doses and dose intervals of the novel long acting beta agonist (LABA), GW642444 in asthmatic subjects…
- Trial name
- NCT00980200
- Testing
- Dose 4 QD, Dose 3 QD, Dose 2 QD
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- GlaxoSmithKline
Migraine
AMG 334 20160172 Pediatric Migraine PK Study.
AMG 334 20160172 Pediatric Migraine PK Study.
- Trial name
- NCT03499119
- Testing
- AMG 334 Dose 1, AMG 334 Dose 2, AMG 334 Dose 3
- Where
- 14 sites in United States
- Volunteers
- 53 people
- Sponsor
- Amgen
Healthy Volunteer
Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of orally administered lomitapide in healthy male Japanese and Caucasian subjects with elevated LDL-C.
- Trial name
- NCT01760187
- Testing
- lomitapide
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Aegerion Pharmaceuticals, Inc.
Multiple Myeloma
Escalating Doses of Thalidomide in Conjunction With Bortezomib and HIgh Dose Melphalan for BSCT
The primary objective of this study is to: Determine the maximum tolerated dose of thalidomide used in conjunction with dose-intense melphalan, bortezomib and autologous (syngeneic) HSC support in the salvage therapy of patients…
- Trial name
- Thal/Mel/Vel (NCT01242267)
- Testing
- Thalidomide+Melphalan +Bortezomib+stem cell transplant
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Hackensack Meridian Health
Heart Failure, Healthy Volunteer
Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients
To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy adults and of ascending multiple oral doses of AMG 986 in heart failure patients (Part C).
- Trial name
- NCT03276728
- Testing
- AMG 986 IV, AMG 986 PO
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Amgen
Migraine
Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients
The primary purpose of this study is to determine whether erenumab is safe and well tolerated in healthy adults and migraine patients.
- Trial name
- NCT01723514
- Testing
- Erenumab
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Tumors Characterized by Genetic Abnormalities of ALK
A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase
This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).
- Trial name
- NCT01283516
- Testing
- LDK378
- Where
- 21 sites in United States, Australia and 9 more
- Volunteers
- 304 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Colorectal Cancer
Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors
The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.
- Trial name
- NCT01927341
- Testing
- MEK162, Panitumumab
- Where
- 8 sites in United States, Belgium and 5 more
- Volunteers
- 53 people
- Sponsor
- Pfizer
NASH - Nonalcoholic Steatohepatitis
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
- Trial name
- NCT04897594
- Testing
- TERN-201
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Meningococcal Infections
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
- Trial name
- NCT00616421
- Testing
- MenACWY-CRM, Licensed meningococcal ACWY vaccine
- Where
- 68 sites in United States, Canada
- Volunteers
- 2,907 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Single- and Multiple-Doses of TAK-020 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ascending single- and multiple-doses of TAK-020 in healthy participants.
- Trial name
- NCT02413255
- Testing
- TAK-020
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Takeda
Alpha 1-Antitrypsin Deficiency
Study of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency Associated Liver Disease (AATD)
The purpose of this study is to evaluate the the safety and efficacy of the investigational product, fazirsiran (TAK-999, ARO-AAT), administered subcutaneously to patients with alpha-1 antitrypsin deficiency associated liver…
- Trial name
- NCT03946449
- Testing
- ARO-AAT
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 16 people
- Sponsor
- Arrowhead Pharmaceuticals
Bladder Cancer
Safety Study of Recombinant Human Hyaluronidase (Chemophase) in Combination With Mitomycin in Participants With Superficial Bladder Cancer
The purpose of this study is to explore a treatment that potentially enhances the delivery of chemotherapy to tumors in participants with superficial bladder cancer.
- Trial name
- NCT00318643
- Testing
- Mitomycin C, Chemophase
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halozyme Therapeutics
Central Neuropathic Pain, Multiple Sclerosis
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules in the treatment of central neuropathic pain in participants with multiple sclerosis.
- Trial name
- PRIME (NCT01324232)
- Testing
- AVP-923-45, AVP-923-30, AVP-923-20
- Where
- 72 sites in United States, Argentina and 3 more
- Volunteers
- 209 people
- Sponsor
- Avanir Pharmaceuticals
Menopause, Postmenopausal Vaginal Atrophy
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.
- Trial name
- NCT00431132
- Testing
- estradiol, 10 mcg
- Where
- 42 sites in Czechia, Denmark and 5 more
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hypercholesterolemia
A Multiple Ascending Dose Study of HTD1801 in Adults With Hypercholesterolemia
This is a randomized, double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety and tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of HTD1801 in overweight to…
- Trial name
- NCT03381287
- Testing
- HTD1801 Tablets, 500 mg, HTD1801 Tablets, 1000 mg, HTD1801 Tablets, 2000 mg
- Where
- 3 sites in Australia
- Volunteers
- 50 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
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