Clinical trials: Normal Healthy Volunteers
Hepatic Impairment
Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib
This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by…
- Trial name
- NCT02621047
- Testing
- Alectinib
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants
The primary objective of this study is to evaluate the effect of filgotinib on a mixed organic anion transporting polypeptide/cytochrome P450 3A (OATP/CYP3A), OATP/ breast cancer resistance protein (BCRP), and OATP substrates…
- Trial name
- NCT04608344
- Testing
- Atorvastatin, Pravastatin, Rosuvastatin
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy
Cefadroxil 500 mg Capsules Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of cefadroxil 500 mg capsules (manufactured by Teva Pharmaceuticals USA) with that of DURICEF® 500 mg capsules (manufactured by Bristol-Myers Squibb Company)…
- Trial name
- NCT00834275
- Testing
- Cefadroxil 500 mg Capsules, DURICEF® capsules 500 mg
- Where
- 2 sites in United States, Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Systemic Lupus Erythematosus
Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab…
- Trial name
- NCT04136145
- Testing
- Belimumab for IV, Belimumab for SC
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus, Hepatic Impairment
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants.
- Trial name
- NCT02115347
- Testing
- Ertugliflozin 15 mg
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
A First-in-Human Safety and Dose-Finding Study of New Type-16 Human Rhinovirus (RG-HRV16) Inoculum in Healthy Volunteers
This research study will test different doses of RG-HRV16 to find the minimum dose needed to give research subjects cold symptoms of at least moderate intensity. The study will also test the safety of RG-HRV16.
- Trial name
- UWI-02 (NCT01769573)
- Testing
- RG-HRV16
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Renal Impairment
A Renal Impairment Study for PF-04965842
This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal…
- Trial name
- NCT03660241
- Testing
- PF-04965842
- Where
- 4 sites in United States, Belgium
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Oxygen Deficiency
Validation of Next Generation Cerebral and Tissue Oximeter
This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
- Trial name
- NCT03128372
- Testing
- Desaturation
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Healthy
Bioenergetic Alterations After Exenatide Administration
The purpose of this study is to find out how exenatide causes weight loss. Specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use…
- Trial name
- NCT00623545
- Testing
- Exenatide
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Muscular Atrophy, Spinal
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function
This is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the PK and safety and tolerability of a single oral dose of risdiplam compared to matched healthy…
- Trial name
- NCT03920865
- Testing
- Risdiplam
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
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
Meloxicam 15 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fed conditions.
- Trial name
- NCT00840879
- Testing
- Meloxicam 15 mg Tablets, Mobic® 15 mg Tablets
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Oxygen Saturation
Comparison of Tissue Oxygenation Measurement Using Multimodal Devices
Pulse oximeters are common medical devices used to measure blood oxygen saturation (SpO2). These devices are either stand-alone or integrated into physiologic monitoring systems, using 2 wavelengths of light to determine SpO2.
- Trial name
- NCT05784103
- Testing
- Clarifi Modulum, Perimed PeriFlux 5000, Apple Watch Oxygen Sensor
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Indiana University
Healthy Subjects, Renal Impairments
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of…
- Trial name
- NCT01491113
- Testing
- Levetiracetam 250 mg, Levetiracetam 500 mg
- Where
- 2 sites in Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Healthy
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the…
- Trial name
- NCT01181726
- Testing
- Estradiol/Norethindrone acetate, Activella®
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Breast Cancer, Non-Small-Cell Lung Cancer
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
The purpose of the study was to conduct a pilot test of new tracers ([18F]FPRGD2 and [18F]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much…
- Conditions
- Breast Cancer, Non-Small-Cell Lung Cancer, Glioblastoma, Other Cancers
- Trial name
- NCT01383135
- Testing
- F18-FPPRGD2
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Stanford University
Healthy
Metformin ER 750 mg Tablets, Fasting
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fasting conditions.
- Trial name
- NCT00834743
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers, Breast Cancer
Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
- Trial name
- CAM-VHH1 (NCT02683083)
- Testing
- [131I]-SGMIB Anti-HER2 VHH1
- Where
- Belgium
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Precirix
Healthy Subjects
Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.
Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin
- Trial name
- NCT03643575
- Testing
- Vicks Cough Syrup for Chesty Coughs, Robitussin Extra Strength Chest Congestion, Organ-I- NR tablet
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Healthy
Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3.
- Trial name
- NCT01468558
- Testing
- MAP0004, IV DHE, Ketoconazole
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allergan