Clinical trials: Safety and Tolerability
Migraine Headache
Study in Participants With Acute Migraines Headaches
This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.
- Trial name
- NCT00804973
- Testing
- LY2590443, Sumatriptan
- Where
- 19 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Non-alcoholic Steatohepatitis
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH
- Trial name
- NCT03812029
- Testing
- Vonafexor
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 120 people
- Sponsor
- Enyo Pharma
Erythropoietic Protoporphyria
Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP
This is a Phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and PPIX concentration change in participants with EPP.
- Trial name
- NCT05308472
- Testing
- DISC-1459
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Disc Medicine, Inc
Type 2 Diabetes Mellitus
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.
- Trial name
- NCT00511472
- Testing
- MK-0941, LANTUS insulin
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
Clostridium Difficile Associated Disease
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules.
- Trial name
- NCT02561195
- Testing
- Clostridium difficile Vaccine
- Where
- 17 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Obstructive Pulmonary Disease (COPD)
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
- Trial name
- TOP (NCT00629239)
- Testing
- AZD4818
- Where
- 12 sites in Denmark, Finland and 3 more
- Volunteers
- 65 people
- Sponsor
- AstraZeneca
Pulmonary Hypertension, Left Heart Disease
A Multiple Dose Titration Study of MK-8892 in Participants With Pulmonary Hypertension and Left Heart Disease (MK-8892-007)
This study will assess multiple doses of MK-8892 administered to participants with pulmonary hypertension "out of proportion" (PHOOP) and heart failure with reduced left ventricular ejection fraction (rEF).
- Trial name
- NCT02078557
- Testing
- MK-8892
- Volunteers
- 4 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Arthritis
A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA…
- Trial name
- NCT02167139
- Testing
- Humira (adalimumab), SB5 (proposed biosimilar to adalimumab)
- Where
- 2 sites in Lithuania, Poland
- Volunteers
- 544 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Respiratory Syncytial Virus
A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants
The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV.
- Trial name
- MORISOT (NCT06325657)
- Testing
- RSVpreF vaccine, Placebp
- Where
- 14 sites in South Africa
- Volunteers
- 681 people
- Sponsor
- Pfizer
HIV, Hepatitis C
Sofosbuvir Based DAA Therapy in HIV/HCV Coinfected Pre or Post Liver Transplant
Retrospective/Prospective, open-label study using sofosbuvir based DAA therapy to treat HIV/HCV coinfected pre or post liver transplant participants
- Conditions
- HIV, Hepatitis C, Cirrhosis
- Trial name
- STOP-CO (NCT02533934)
- Testing
- Harvoni
- Where
- 8 sites in United States
- Volunteers
- 68 people
- Sponsor
- University of California, San Francisco
Psoriasis
Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
- Trial name
- NCT00975637
- Testing
- 70 mg SC, 210 mg SC, 140 mg SC
- Volunteers
- 198 people
- Sponsor
- Bausch Health Americas, Inc.
Type 2 Diabetes Mellitus
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or…
- Trial name
- NCT00511667
- Testing
- MK0941
- Volunteers
- 70 people
- Sponsor
- Merck Sharp & Dohme LLC
Epilepsy, Partial-onset Seizures
A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures
This study is to evaluate the long-term safety and tolerability of Lacosamide (LCM) 200 mg/day to LCM 600 mg/day taken in monotherapy in Japanese subjects who currently have partial-onset seizures with or without secondary…
- Trial name
- NCT02124564
- Testing
- Lacosamide
- Where
- 11 sites in Japan
- Volunteers
- 19 people
- Sponsor
- UCB Japan Co. Ltd.
Ulcerative Colitis
Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission
To evaluate the long-term safety and tolerability of encapsulated mesalamine Granules (eMG) (formerly referred to as Mesalamine Pellets [MP]) in participants with ulcerative colitis currently in remission.
- Trial name
- NCT00326209
- Testing
- Encapsulated Mesalamine Granules (eMG)
- Where
- 61 sites in United States
- Volunteers
- 393 people
- Sponsor
- Bausch Health Americas, Inc.
Type 2 Diabetes
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to 17 year old diabetic patients.
- Trial name
- NCT00730275
- Testing
- Sitagliptin phosphate
- Volunteers
- 35 people
- Sponsor
- Merck Sharp & Dohme LLC
Ovarian Cancer
Phase Ib/II Study of Carboplatin + M6620 + Avelumab in PARPi-resistant Ovarian Cancer
The study was to evaluate the efficacy and safety of avelumab in combination with M6620 + carboplatin in participants with PARPi-resistant, recurrent, platinum sensitive ovarian, primary peritoneal, or fallopian tube cancer.
- Trial name
- NCT03704467
- Testing
- M6620, Avelumab, Carboplatin
- Where
- 13 sites in United States, Belgium and 1 more
- Volunteers
- 3 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Pain
A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury
A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.
- Trial name
- NCT01606202
- Testing
- GW-1000-02
- Where
- United Kingdom
- Volunteers
- 116 people
- Sponsor
- Jazz Pharmaceuticals
Endometriosis
BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
- Trial name
- NCT01190475
- Testing
- Active treatment with a high dose of BGS649, Active treatment with a low dose of BGS649
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mereo BioPharma
Rheumatoid Arthritis
First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts
This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a…
- Trial name
- NCT05576012
- Testing
- SOL-116
- Where
- 2 sites in Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Lipum AB
Myelodysplastic Syndromes
A Phase Ib Study Evaluating the Safety and Tolerability of Vitamin C in Patients With Intermediate or High Risk Myelodysplastic Syndrome With TET2 Mutations
This is an open label, Phase Ib study designed to evaluate the safety, toxicity and biological activity of high dose Vitamin C in bone marrow and peripheral blood when administered as therapy to patients with intermediate or high…
- Trial name
- NCT03433781
- Testing
- Vitamin C
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- NYU Langone Health
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