Clinical trials: Drug Kinetics
TTR-mediated Amyloidosis
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
- Trial name
- NCT01617967
- Testing
- Patisiran
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 29 people
- Sponsor
- Alnylam Pharmaceuticals
Non Hematologic Cancers
Phase I Dose Escalation Study of VS-6063 in Japanese Subjects With Non-Hematologic Malignancies
This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies.
- Trial name
- NCT01943292
- Testing
- Defactinib
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Verastem, Inc.
Fungal Infection
Safety and Pharmacokinetics of Rezafungin
This is a Phase 1, double-blind, placebo-controlled trial in three parts. A single ascending dose (SAD) study in six cohorts receiving a single subcutaneous (SC) dose of 1, 10, 30, 60, 100, or 200 mg of rezafungin; a multiple…
- Trial name
- NCT04117607
- Testing
- Rezafungin
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chronic Hepatitis C
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24…
- Trial name
- NCT01359644
- Testing
- PSI-7977, Daclatasvir, Ribavirin
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- Bristol-Myers Squibb
Anesthesia
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
The purpose of this study is: to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants…
- Trial name
- NCT00421148
- Testing
- Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Papulopustular Rosacea
Safety, Efficacy and Pharmacokinetics of Rifaximin in Patients With Moderate-to-severe Papulopustular Rosacea
Rosacea is a common chronic inflammatory relapsing-remitting skin condition almost exclusively affecting the central area of the face and the eyes.
- Trial name
- NCT05150587
- Testing
- Rifaximin
- Where
- 38 sites in United States
- Volunteers
- 216 people
- Sponsor
- Alfasigma S.p.A.
Multiple Myeloma
First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed…
- Trial name
- NCT04075721
- Testing
- M3258, M3258 20 mg
- Where
- 7 sites in United States, France
- Volunteers
- 10 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Skin and Subcutaneous Tissue Bacterial Infections, Gram-Positive Bacterial Infections
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.
- Trial name
- P2_ABSSSI (NCT03964493)
- Testing
- TNP-2092, Vancomycin
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- TenNor Therapeutics Limited
Lysosomal Acid Lipase Deficiency, Wolman Disease
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency.
- Trial name
- NCT01371825
- Testing
- Sebelipase alfa (SBC-102)
- Where
- 7 sites in United States, Egypt and 3 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
- Trial name
- NCT02706834
- Testing
- TAK-828
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Type 2 Diabetes Mellitus
A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
A Phase 2 study with two cohorts of differing doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in patients with Type 2 Diabetes Mellitus (T2DM).
- Trial name
- NCT03244800
- Testing
- MEDI0382
- Where
- 5 sites in Germany
- Volunteers
- 65 people
- Sponsor
- MedImmune LLC
Pterygium
Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24) Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup (n=51)
- Trial name
- Pterygium (NCT03049852)
- Testing
- CBT-001 single dose, Vehicle, CBT-001 Multi-dose
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Cloudbreak Therapeutics, LLC
Crohn's Disease
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug).
- Trial name
- OPERA (NCT01276509)
- Testing
- PF-00547659 SC injection
- Where
- 137 sites in United States, Austria and 14 more
- Volunteers
- 265 people
- Sponsor
- Shire
Healthy Volunteers
A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants
The main purpose of this study is to look at the effect of ketoconazole and fluconazole on how much baricitinib gets into the blood stream.
- Trial name
- NCT01924299
- Testing
- Baricitinib, Ketoconazole, Fluconazole
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Anaemia
4 Week Correction Study in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Undergoing Dialysis
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia…
- Trial name
- NCT01587898
- Testing
- GSK1278863
- Where
- 55 sites in United States, Canada and 1 more
- Volunteers
- 72 people
- Sponsor
- GlaxoSmithKline
COVID 19
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Renal Impairment and in Healthy Subjects With Normal Renal Function
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with severe renal impairment and subjects without renal impairment, matched for age, body weight and, to the extent…
- Trial name
- NCT06698549
- Testing
- ALG-097558
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Dental Caries
Pharmacokinetics of Advantage Arrest
The study aim is to characterize the kinetics of silver and fluoride after topical application of silver diamine fluoride.
- Trial name
- NCT04184271
- Testing
- 38% silver diamine fluoride
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Advantage Silver Dental Arrest, LLC
Hepatorenal Syndrome
Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients
A study of ifetroban in the treatment of hepatorenal syndrome (HRS) in hospitalized adult patients to assess the safety and pharmacokinetics of 3 days of intravenous ifetroban.
- Trial name
- NCT01436500
- Testing
- Ifetroban Injection
- Where
- 12 sites in United States, India
- Volunteers
- 55 people
- Sponsor
- Cumberland Pharmaceuticals
Postpartum Depression
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum…
- Trial name
- NCT02942004
- Testing
- SAGE-547 60 μg/kg/h, SAGE-547 90 μg/kg/h
- Where
- 32 sites in United States
- Volunteers
- 138 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Healthy
A Study of LY3493269 in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in healthy participants. The blood tests will be performed to check how much LY3493269 gets into the bloodstream, how long the body takes to…
- Trial name
- NCT04682106
- Testing
- LY3493269, Salcaprozate Sodium
- Where
- Singapore
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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