Clinical trials: Biological Markers
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis
A Study of LY2127399 in Rheumatoid Arthritis
This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate.
- Trial name
- NCT01576549
- Testing
- LY2127399
- Where
- 4 sites in United States
- Volunteers
- 2 people
- Sponsor
- Eli Lilly and Company
Non-Squamous Non-Small Cell Lung Cancer
A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)
This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy.
- Trial name
- MERIT (NCT02774278)
- Testing
- Erlotinib
- Where
- 29 sites in Belgium, Bulgaria and 12 more
- Volunteers
- 264 people
- Sponsor
- Hoffmann-La Roche
FGFR Inhibition, Pharmacokinetics, Biomarkers, ER+ Breast Cancer
Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients
The purpose of this study is to assess the safety and effectiveness of AZD4547 in combination with fulvestrant vs. fulvestrant alone in ER+ breast cancer patients with FGFR1 polysomy (FISH4/5) or gene amplification (FISH 6)
- Trial name
- GLOW (NCT01202591)
- Testing
- AZD4547, Exemestane, Fulvestrant
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 127 people
- Sponsor
- AstraZeneca
Churg-Strauss Syndrome
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram [mg] administered subcutaneously [SC] every 4 weeks) compared with placebo over a 52-week study treatment…
- Trial name
- NCT02020889
- Testing
- Mepolizumab
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 136 people
- Sponsor
- GlaxoSmithKline
Drug-drug Interaction Study
A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin
The goal of this clinical study was to determine the effect of the test drug ceftobiprole (a drug approved for the treatment of bacterial infections) on the elimination of pitavastatin (a drug approved for the treatment of…
- Trial name
- NCT06808646
- Testing
- pitavastatin, pitavastatin single dose combined with ceftobiprole
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Amyloidosis
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by…
- Trial name
- NCT03044353
- Testing
- GSK2315698 (CPHPC), GSK2398852 (anti-SAP mAb)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Growth Hormone Deficiency
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects…
- Trial name
- OraGrowtH210 (NCT04614337)
- Testing
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Where
- 43 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Lumos Pharma
Metastatic Breast Cancer
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally…
- Trial name
- NCT01663727
- Testing
- Bevacizumab [Avastin], Paclitaxel
- Where
- 178 sites in United States, Argentina and 14 more
- Volunteers
- 481 people
- Sponsor
- Hoffmann-La Roche
Tobacco Use
Changes in Biomarker of Exposure in Adults Who Smoke Cigarettes Switching From Cigarettes to Heated Tobacco Products
The purpose of the study is to evaluate changes in biomarkers of exposure (BoE) to harmful and potentially harmful constituents (HPHCs) in adult smokers who completely switch to Ploom heated tobacco products (HTPs) compared to…
- Trial name
- NCT06179290
- Testing
- Ploom HTP Menthol HTS; MX3 (681), Ploom HTP Tobacco HTS; R8 (120), Smoking Abstinence (menthol)
- Where
- 8 sites in United States
- Volunteers
- 921 people
- Sponsor
- Altria Client Services LLC
Acute Myeloid Leukemia
Alvocidib Biomarker-driven Phase 2 AML Study
The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML…
- Trial name
- NCT02520011
- Testing
- Alvocidib, Cytarabine, Mitoxantrone
- Where
- 38 sites in United States, Canada and 2 more
- Volunteers
- 104 people
- Sponsor
- Sumitomo Pharma America, Inc.
Chronic Obstructive Pulmonary Disease
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.
- Trial name
- BICO (NCT00758706)
- Testing
- AZD1236
- Where
- 10 sites in Denmark, Finland and 2 more
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Schizophrenia, Mental Disorder
Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
- Conditions
- Schizophrenia, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02219009
- Testing
- MIND1 System
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Asthma
A Phase IIA FF/VI Study to Measure FeNO in Asthmatic Patients.
For asthmatic subjects, a combination of inhaled corticosteroid (FF) and long-acting beta2 receptor agonist (VI) is recommended for use (once daily) and fraction of exhaled nitric oxide (FeNO) is a non-invasive airway…
- Trial name
- NCT02712047
- Testing
- Fluticasone furoate (FF) (100 mcg), Vilanterol (VI) (25 mcg)
- Where
- New Zealand
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Non-Small Cell Lung Cancer
A Study of Avastin (Bevacizumab) in Combination With Carboplatin-Based Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer.
This study will explore the correlation of biomarkers with response rate, and the overall efficacy and safety, of Avastin in combination with carboplatin-based chemotherapy in patients with advanced or recurrent non-squamous…
- Trial name
- NCT00700180
- Testing
- bevacizumab [Avastin], Carboplatin-based chemotherapy
- Where
- 59 sites in Australia, Belgium and 14 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers
A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers
This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and…
- Trial name
- NCT02005211
- Testing
- AZD3293
- Where
- Japan
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days.
- Trial name
- NCT04430634
- Testing
- Myblu variant A, Myblu variant B, Myblu variant C
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Fontem US LLC
Pulmonary Disease, Chronic Obstructive
A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation
The purpose of this study is to evaluate specific alterations in immune cell mechanisms related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger ribonucleic acid (mRNA) extracted from induced sputum…
- Trial name
- NCT02522299
- Testing
- GSK2269557, DISKUS, ELLIPTA
- Where
- 6 sites in Canada, Denmark
- Volunteers
- 44 people
- Sponsor
- GlaxoSmithKline