Clinical trials: Normal Healthy
Renal Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Normal Renal Function or With Severe Renal Impairment
This study will be conducted to assess the effect of severe renal impairment on the pharmacokinetics of lemborexant after a single-dose administration.
- Trial name
- NCT03443063
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Healthy Volunteers, Renal Impairment
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe)…
- Trial name
- NCT04476849
- Testing
- fezolinetant
- Where
- 7 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic Impairment, Healthy Participants
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600.
- Trial name
- NCT04016077
- Testing
- PF-06651600 30 mg
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.
Hereditary Angioedema
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and…
- Trial name
- NCT02448264
- Testing
- BCX7353
- Where
- United Kingdom
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Trial name
- NCT06037577
- Testing
- CM-101
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- ChemomAb Ltd.
Pigmentation, Redness
Photoprotection Efficacy With Sunscreen Formulas Containing the Cyclic Merocyanine Long-UVA Absorber MCE Under Long-UVA Exposure
To evaluate the photo-protector effect of BC_3 (E212657) formulated in SPF compared to SPF alone on long-UVA induced pigmentation in healthy volunteers.
- Trial name
- NCT04865094
- Testing
- cyclic merocyanine
- Where
- Romania
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- L'Oreal
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function.
- Trial name
- NCT04942964
- Testing
- Bocidelpar
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Breast Cancer
Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential
This study is to assess the pharmacokinetics (PK) of a single dose of pravastatin with and without concomitant GDC-0810 administration in healthy female subjects of non-childbearing potential.
- Trial name
- NCT02621957
- Testing
- GDC-0810, Pravastatin
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Renal Impairment
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants.
The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on pharmacokinetics (PK), safety and tolerability of…
- Trial name
- NCT05282030
- Testing
- tolebrutinib
- Where
- 4 sites in United States, Germany
- Volunteers
- 22 people
- Sponsor
- Sanofi
Healhty, Overweight or Obesity
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812…
- Trial name
- NCT07224399
- Testing
- BGM1812
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
Diabetes, Healthy
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects…
- Trial name
- NCT00976326
- Testing
- insulin degludec
- Where
- Slovakia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy Volunteers
A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833
AstraZeneca AB is developing the test medicine, AZD9833, for the potential treatment of oestrogen receptor (ER) positive breast cancer.
- Trial name
- NCT04546347
- Testing
- [14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL), AZD9833 film-coated tablet A Dose 1, AZD9833 Oral Solution
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers
This study will test the safety and tolerability (how the body reacts to the drug) of REGN668 and placebo (an inactive substance that contains no medicine) in healthy subjects.
- Trial name
- NCT01015027
- Testing
- REGN668
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib
This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.
- Trial name
- NCT03627754
- Testing
- Glasdegib 100 mg single oral dose
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Epilepsy
Bioequivalence Study of Perampanel Tablets 12 mg
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 12 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 12 mg film-coated tablets…
- Trial name
- NCT06450223
- Testing
- Perampanel 12 MG, Fycompa 12 mg film-coated tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Cervical Cancers, Vulvar Cancer
Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.
- Conditions
- Cervical Cancers, Vulvar Cancer, Vaginal Cancer, CIN1
- Trial name
- NCT03676101
- Testing
- 9-valent HPV Recombinant Vaccine
- Where
- China
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shanghai Bovax Biotechnology Co., Ltd.
Healthy, Renal Insufficiency
A Study of Effect of Selpercatinib (LY3527723) in Participants With Normal and Impaired Renal Function
The main purpose of this study is to assess the amount of study drug that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to healthy…
- Trial name
- NCT05469100
- Testing
- Selpercatinib
- Where
- 6 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hypercholesterolemia
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Primary Objective: Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).
- Trial name
- NCT01670734
- Testing
- alirocumab SAR236553 (REGN727)
- Where
- 2 sites in France, Moldova
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sanofi
Acne Vulgaris
Open-label Safety and Tolerability Study of LTS-PDT in Healthy Volunteers
The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.
- Trial name
- NCT01830764
- Testing
- Red Light (PDT)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Dermira, Inc.
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