Clinical trials: Exposure
Antivirals/HIV
Drug Interaction Study
The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)
- Trial name
- NCT00646776
- Testing
- Rifabutin, Rifabutin + Atazanavir + Ritonavir
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Immunocompromised
A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults
The primary objective of the study is to evaluate the effect of casirivimab+imdevimab, compared with placebo, in preventing symptomatic SARS-CoV-2 infection in immunocompromised participants.
- Trial name
- NCT05074433
- Testing
- casirivimab+imdevimab
- Where
- 67 sites in United States, Mexico
- Volunteers
- 66 people
- Sponsor
- Regeneron Pharmaceuticals
Gadolinium Retention
Evaluation of Gd Retention in Human Bone and Skin After MultiHance or ProHance Administration Compared With Control
Subjects must be scheduled to undergo an orthopedic surgical procedure. Subjects in the non-control group must have previously received an MRI with MultiHance or ProHance with at least 1 month between the last administration and…
- Trial name
- NCT03108378
- Testing
- Surgery
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Bracco Diagnostics, Inc
Tuberculosis
Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa
Goal of Serum Institute of India Limited (SIIL) is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis…
- Trial name
- NCT02391415
- Testing
- VPM1002, BCG, VPM1002(Hyg+)
- Where
- 4 sites in South Africa
- Volunteers
- 416 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Primary Axillary Hyperhidrosis
Assessment of Safety, Tolerability, Systemic Exposure and Efficacy of GPB Cream in Adolescents With Severe Primary Hyperhidrosis
The aim of this study is to evaluate the safety, tolerability and systemic exposure (in a subset of patients) of topical administration of 1% GPB in adolescents with severe primary axillary hyperhidrosis.
- Trial name
- NCT05863104
- Testing
- Glycopyrronium Bromide (GPB) Cream
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Seasonal Allergic Rhinitis
Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber
The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen
- Trial name
- NCT02061709
- Testing
- Ragweed-SPIRE
- Where
- 5 sites in Canada
- Volunteers
- 280 people
- Sponsor
- Circassia Limited
Precocious Puberty, Gonadotropin-dependent
(Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty
The goal of this clinical trial is to evaluate the safety, tolerability, and blood levels of (Z)-endoxifen in girls with McCune-Albright Syndrome that have peripheral precocious puberty.
- Trial name
- NCT07869732
- Testing
- (Z)-endoxifen
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Atossa Therapeutics, Inc.
Pregnant
DV2-HBV-27: Observational Pregnancy Registry
Purpose of the study is to evaluate pregnancy outcomes among women who received a dose of HEPLISAV-B within 28 days prior to conception or at any time during pregnancy
- Trial name
- HBV-27 (NCT03664648)
- Testing
- HEPLISAV-B
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Study to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous (SC) Peginterferon Beta-1a and Intramuscular (IM) Interferon Beta-1a Reported in a German Participant Support Program
The primary objective(s) of the study is to evaluate the impact of exposure to SC Peginterferon beta-1a or IM Interferon beta-1a before and during pregnancy on pregnancy outcome in female participants who had registered in the…
- Trial name
- NCT04655222
- Testing
- Interferon Beta Therapy
- Where
- Germany
- Volunteers
- 470 people
- Sponsor
- Biogen
Blood and Lymphatic Diseases
Long - Term Follow Up of Sickle Cell Disease and Beta-thalassemia Subjects Previously Exposed to BIVV003 or ST-400.
Primary Objectives: Long-term safety of BIVV003 in participants with severe sickle cell disease (SCD) and ST- 400 in participants with transfusion-dependent beta-thalassemia (TDT) Secondary Objectives: Long-term efficacy of the…
- Trial name
- NCT05145062
- Testing
- BIVV003, ST-400
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Sangamo Therapeutics
Healthy
Clinical Evaluation of the Photoallergy Potential of Atralin Gel
To assess the potential of tretinoin gel 0.05% and its vehicle to produce photoallergic reactions, measured as skin reactions following induction and challenge.
- Trial name
- NCT00603772
- Testing
- Atralin (tretinoin) gel, 0.05%
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Coria Laboratories, Ltd.
Lead Poisoning, Environmental Exposure
A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure
This clinical trial aims to evaluate the effectiveness of targeted public health campaigns in reducing lead exposure among adults living in urban communities with known environmental lead hazards.
- Trial name
- NCT07632937
- Testing
- Intensive Public Health Campaign, Standard Information Dissemination
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- International Health Strategies LLC
Evaluation of QTc Interval
An Open-Label, Single-Center Study to Evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc at Steady State Following Once-daily Administration of CASSIPA® in Opioid Dependent Subjects.
The objective of this study is to evaluate the exposure-response relationship between the steady-state plasma concentrations of buprenorphine, norbuprenorphine, naloxone, and total naloxone and the change from baseline in QTc…
- Trial name
- NCT04088266
- Testing
- 16 mg buprenorphine with 4 mg naloxone sublingual film
- Sponsor
- Teva Pharmaceuticals USA
Allergic Rhinoconjunctivitis
A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber
The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure…
- Trial name
- NCT02481856
- Testing
- SQ tree SLIT-tablet
- Where
- Canada
- Volunteers
- 219 people
- Sponsor
- ALK-Abelló A/S
Visible Light Exposure on Healthy Back Skin
Photoprotection Efficacy of Different Topical Agents Under Visible Light Exposure
To evaluate the protective effect of seven sunscreens on the pigmentation induced by visible light in comparison to an untreated control zone in healthy volunteers
- Trial name
- NCT06796153
- Testing
- Visible Light Exposure - Treated zones, Visible Light Exposure - Untreated zone
- Where
- Romania
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Cosmetique Active International
Multiple Sclerosis
The Gilenya Pregnancy Registry
The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to…
- Trial name
- NCT01285479
- Testing
- Fingolimod
- Where
- 61 sites in United States, Argentina and 32 more
- Volunteers
- 312 people
- Sponsor
- Novartis Pharmaceuticals
Diabetes, Diabetes Mellitus, Type 1
A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this trial is to investigate the exposure of NN5401 (insulin degludec/insulin aspart) in young adults and elderly subjects with type 1 diabetes mellitus.
- Trial name
- NCT01174303
- Testing
- insulin degludec/insulin aspart, biphasic insulin aspart 30
- Where
- Austria
- Volunteers
- 28 people
- Sponsor
- Novo Nordisk A/S
Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III).
- Trial name
- NCT02251756
- Testing
- Actinica, 0.8 mg/cm2, 1 application, Actinica, 0.8 mg/cm2, 2 applications, Actinica, 2 mg/cm2, 1 application
- Where
- France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program
CAR-T Long Term Follow Up (LTFU) Study
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required.
- Trial name
- PAVO (NCT02445222)
- Testing
- Previously treated CAR-T patients
- Where
- 120 sites in United States, Australia and 21 more
- Volunteers
- 1,105 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients
The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.
- Trial name
- NCT00830102
- Testing
- fluticasone propionate, formoterol fumarate
- Where
- 6 sites in Ireland, United Kingdom
- Volunteers
- 64 people
- Sponsor
- SkyePharma AG