Clinical trials: Healthy Participants Study
Pharmacokinetic
A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248
The study will collect information about pharmacokinetics (PK), safety and tolerability following a single dose of GS-248 in two different oral solid formulations in capsules to healthy subjects.
- Trial name
- NCT04617509
- Testing
- Formulation A GS-248, Formulation B GS-248
- Where
- Sweden
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Gesynta Pharma AB
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 Participants
Riluzole Orodispersible Film Replicate Bioavailability
The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their…
- Trial name
- NCT04819438
- Testing
- Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets
- Where
- Switzerland
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Cross Research S.A.
Mild and Moderate Renal Impairment
Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function
The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.
- Trial name
- NCT01569815
- Testing
- LCZ696
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01770652
- Testing
- Deferiprone
- Where
- 2 sites in Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Healthy
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
- Trial name
- NCT01857362
- Testing
- Nitisinone 20 mg, Nitisinone 10 mg
- Where
- Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Swedish Orphan Biovitrum
Healthy Adult Subjects
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05.
- Trial name
- NCT05632211
- Testing
- AVT05, Simponi
- Where
- 2 sites in New Zealand, United Kingdom
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Influenza
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms
- Trial name
- NCT03653364
- Testing
- Baloxavir Marboxil
- Where
- 27 sites in United States, Bulgaria and 7 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Bleeding
A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
"This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and…
- Trial name
- NCT03310021
- Testing
- Andexanet alfa, Apixaban, Rivaroxaban
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
Major Depressive Disorder
A Study of LY2216684 and Theophylline in Healthy Subjects
The primary objective of this study is to confirm that LY2216684 is not an inhibitor of cytochrome P450 1A2 (CYP1A2) in healthy participants using theophylline as a probe substrate for the enzyme.
- Trial name
- NCT01263106
- Testing
- LY2216684, Theophylline
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Volunteers
A Study of LY2605541 in Healthy Participants
This study looks at the amount of LY2605541 in the body after it is injected under the skin. The study has 3 periods, each lasting 10 days. Each participant will receive one injection in each period.
- Trial name
- NCT01877265
- Testing
- LY2605541
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects
This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085.
- Trial name
- NCT02380287
- Testing
- humanized monoclonal antibody against human IL-17
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Biocad
Healthy
Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference) administered as the content of 1 x 10 mg capsule mixed with applesauce under fasting…
- Trial name
- NCT00829452
- Testing
- Ramipril 10 mg capsule, Altace® 10 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Subjects (HS)
A Study to Evaluate the Safety, Biodistribution, Internal Radiation Dosimetry, and Effective Dose of DaTSCAN™ Ioflupane (123I) Injection in Chinese Healthy Volunteers.
This is a phase 1, single-centre, single-group, nonrandomized, noncomparative, open-label, single-dose study to evaluate the safety, biodistribution, internal radiation dosimetry, and effective dose of DaTSCAN™ ioflupane (123I)…
- Trial name
- NCT04564092
- Testing
- DaTSCAN™ Ioflupane (123I) Injection
- Where
- China
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- GE Healthcare
Healthy Volunteers
Cardiac Safety Evaluation of P03277
The study is a Phase I, Single center, Randomized, Cross-over Double-blind Placebo-controlled and Open-label Positive-controlled (moxifloxacin) in healthy volunteers.
- Trial name
- NCT03657264
- Testing
- P03277 0.1 mmol/kg, Moxifloxacin 400mg, NaCl 0.9%
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Guerbet
Chronic Hepatitis B
Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection
This is a Phase 1 study in which healthy volunteers and participants with chronic HBV infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability, pharmacokinetics (PK), and antiviral activity (only…
- Trial name
- NCT04423393
- Testing
- VIR-3434
- Where
- 24 sites in Germany, Hong Kong and 5 more
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Healthy Volunteers
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects.
- Trial name
- NCT02088697
- Testing
- ASC-01
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Fear Pain
Human Behaviors Related to the Expectation of Pain
The conditioned expectation of pain is an important aspect of pain-related disability produced by environments and stimuli associated with a painful injury on the job, although the neuroscience of this expectation is unclear.
- Trial name
- NCT03739645
- Testing
- Skin conductance levels and slopes over time in conditioned fear as metrics.as metrics for anxiety
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Healthy
A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants
The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled…
- Trial name
- NCT04840901
- Testing
- Lebrikizumab
- Where
- 4 sites in United States
- Volunteers
- 242 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Subcutaneous Fat
A Study to Evaluate the Pharmacokinetic Profile of CBL-514 Injection in Healthy Volunteers
This Phase 2 study will be an open-label and single course study to assess the safety, tolerability, PK and metabolite profile of CBL-514.
- Trial name
- NCT05234736
- Testing
- CBL-514
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
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