Clinical trials: Normal Healthy Subjects
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Healthy Volunteers
The Brain Alerting Mechanism Study
This is a study designed to look at how arousal levels in the brain change with age and how these changes influence thinking, vision, hearing and physical function in people of advanced age.
- Trial name
- NCT02050386
- Testing
- Cold pressor stimulation
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Florida
Healthy, Hepatic Impairment
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
The main objective of this study is to compare the pharmacokinetics (PK) of a single oral 75 mg dose of cabozantinib in hepatic impaired adult subjects to healthy adult subjects.
- Trial name
- NCT01493869
- Testing
- cabozantinib
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Exelixis
Renally Impaired Subjects
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1…
- Trial name
- NCT02313103
- Testing
- lofexidine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Fasting State
Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fasting Condition
This is a single-dose, Randomized, two-period,cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding Reference Product under fasting condition in normal…
- Trial name
- NCT01557439
- Testing
- Levocetirizine Dihydrochloride 5 mg Tablets
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Recurrent/Metastatic Breast Cancer
Clinical Trial for Effect of TQB3616 Capsule on Pharmacokinetics in Healthy Adult Subjects
TQB3616 capsule is a small molecule oral drug developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., which inhibits cyclin-dependent kinases 4 and 6 (CDK4/6).
- Trial name
- NCT05344729
- Testing
- TQB3616 Capsule
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy Volunteer, Renal Impairment
Study of AT-527 in Subjects With Normal and Impaired Renal Function
Study of AT-527 in Subjects with Normal and Impaired Renal Function
- Trial name
- NCT05618314
- Testing
- AT-527, AT-527 and Probenecid
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Psoriatic Arthritis
A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®
This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed…
- Trial name
- NCT05332730
- Testing
- BAT2506 injection, Simponi® (EU commercially available product), Simponi® (US commercially available product)
- Where
- China
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Bio-Thera Solutions
Anthrax
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Primary: To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo Secondary: To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9 To evaluate…
- Trial name
- NCT01202695
- Testing
- AVP-21D9
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Behaviour
Evaluation of Behaviour in Parkinson's Disease. Normal Values in Healthy Subjects
Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment and must be considered in treatment policies.
- Trial name
- ECMP (NCT02820428)
- Testing
- Healthy participants
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- University Hospital, Grenoble
Healthy, Renal Insufficiency
Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).
- Trial name
- NCT04154670
- Testing
- MGTA-145
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Ensoma
Asthma, Atopic Dermatitis
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and…
- Conditions
- Asthma, Atopic Dermatitis, Healthy
- Trial name
- NCT02345928
- Testing
- Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, Part 2 (Atopic Dermatitis): CNTO 7160
- Where
- 7 sites in Belgium, Germany
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
Analysis of Diphenylcyclopropenone (DPCP) in Normals
The drug diphenylcyclopropenone, or DPCP, modifies the immune system and has been shown to be effective in treating certain kinds of cancer.
- Trial name
- NCT01452594
- Testing
- Diphenylcyclopropenone
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Diabetes, Wound Infection
Tissue Penetration of Ceftolozane/Tazobactam in Diabetic Patients With Lower Limb Infections
This study will determine the tissue penetration of ceftolozane/tazobactam (Zerbaxa, Merck \& Co.), a novel β-lactam/β-lactamase combination antibiotic, into the extracellular, interstitial fluid of soft tissue in diabetic…
- Conditions
- Diabetes, Wound Infection, Healthy Volunteers
- Trial name
- NCT02620774
- Testing
- Ceftolozane/tazobactam, Microdialysis Catheter Insertion
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Hartford Hospital
Cerebrovascular Disease, Stroke
Genetic Studies to Identify Stroke Subtypes and Outcome
This study will characterize the gene response of the body's immune and inflammatory cells to stroke. There is a wide variation in stroke risk, stroke outcome, and response to clot-busting therapy for stroke.
- Trial name
- NCT00357513
- Where
- 3 sites in United States
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Tropical Spastic Paraparesis
MRI Brain Studies in Patients With HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
This study will use three different magnetic resonance imaging (MRI) techniques to study HTLV-1 associated myelopathy/tropical spastic paraparesis (HAM/STP)-a disease of slowly progressive weakness in the legs.
- Trial name
- NCT00034723
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Healthy
Pilot Study: Effects of G-CSF on T Cell Function
This study will evaluate changes in T cells-infection-fighting white blood cells of the immune system-in people given a drug called G-CSF before donating stem cells (immature bone marrow cells) for transplantation.
- Trial name
- NCT00039650
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Hepatic Insufficiency
Evaluate the Pharmacokinetics, Safety, and Tolerability of Alisporivir in Subjects With Hepatic Impairment Compared to Healthy Subjects
This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of single oral doses of Alisporivir in subjects with mild and moderate hepatic impairment compared to matched healthy subjects with normal…
- Trial name
- NCT01860326
- Testing
- Alisporivir
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Debiopharm International SA
Healthy
Gastric Tolerability and Pharmacokinetics of DMMET-01
The purpose of this study is to determine the gastric tolerability and the pharmacokinetics of a new drug for the treatment of type 2 diabetes, DMMET-01, in healthy volunteers.
- Trial name
- NCT00960882
- Testing
- DMMET-01
- Where
- Mexico
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Laboratorios Silanes S.A. de C.V.
Fasting
Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01735318
- Testing
- Lisinopril Tablets 40 mg, Lisinopril
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
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