Clinical trials: Single Dose
Infections, Bacterial
A Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK1322322 in Healthy Subjects
This study is an open-label, randomized, single dose, four period, balanced crossover study to assess in eligible healthy male or female subjects.
- Trial name
- NCT01648179
- Testing
- GSK1322322 (mesylate salt) Powder for Injection, GSK1322322 (freebase) tablets, GSK1322322 (mesylate salt) Powder for Oral Solution
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication.
- Trial name
- NCT00821496
- Testing
- ethinyl estradiol, norethindrone, VI-0521
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- VIVUS LLC
Infections, Bacterial
Pharmacokinetic Study of Oral Gepotidacin (GSK2140944) in Subjects With Uncomplicated Urinary Tract Infection (Acute Cystitis)
Gepotidacin (GSK2140944) is a novel triazaacenaphthylene bacterial type II topoisomerase inhibitor that is being developed for the treatment of uncomplicated urinary tract infections (UTIs; acute cystitis).
- Trial name
- NCT03568942
- Testing
- Gepotidacin
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
KD025 Hepatic Impairment Study With Normal Hepatic Function and Subjects With Varying Degrees of Hepatic Impairment
This is a study to characterize the pharmacokinetics, safety and tolerability of KD025 and KD025 metabolites in subjects with mild, moderate or severe hepatic impairment compared to healthy subjects with normal hepatic function.
- Trial name
- NCT04166942
- Testing
- KD025
- Where
- 5 sites in United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Healthy
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Participants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses.
- Trial name
- NCT03151486
- Testing
- JNJ-55308942 0.5 mg, JNJ-55308942 1.5 mg, JNJ-55308942 4 mg
- Where
- Belgium
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV
Acute Watery Diarrhea, Dysentery/Febrile Diarrhea
Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea
The purpose of the trial is to develop the evidence on relative efficacy of 3 available single-dose loperamide adjuncted regimens for watery diarrhea and a single-dose regimen, with and without loperamide, for dysentery/febrile…
- Trial name
- TrEAT TD (NCT01618591)
- Testing
- Single dose rifaximin 1650 mg, Single dose azithromycin 500 mg, Single dose levofloxacin 500 mg
- Where
- 5 sites in Afghanistan, Djibouti and 3 more
- Volunteers
- 384 people
- Sponsor
- Uniformed Services University of the Health Sciences
Age-Related Maculopathy
Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)
The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular…
- Trial name
- NCT00056823
- Testing
- rhuFab V2 (ranibizumab)
- Volunteers
- 168 people
- Sponsor
- Genentech, Inc.
Leber Congenital Amaurosis 10, Inherited Retinal Dystrophies
Single Ascending Dose Study in Participants With LCA10
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single escalating doses of EDIT-101 administered via subretinal injection in participants with LCA10 caused by a homozygous or compound…
- Conditions
- Leber Congenital Amaurosis 10, Inherited Retinal Dystrophies, Eye Diseases, Hereditary, Retinal Disease
- Trial name
- NCT03872479
- Testing
- EDIT-101
- Where
- 5 sites in United States
- Volunteers
- 34 people
- Sponsor
- Editas Medicine, Inc.
Heart Failure, Congestive
A Phase I Study to Assess the Pharmacokinetics of GSK2798745 Tablets
GSK2798745 is being developed as a novel therapeutic intervention for the treatment of pulmonary edema associated with heart failure (HF) and is currently under investigation in the form of a compounded capsule.
- Trial name
- NCT02925546
- Testing
- GSK2798745 Micronized API without SLS and hypermellose (Tablet A), GSK2798745 Micronized API with SLS and hypermellose (Tablet B), GSK2798745 milled API without SLS and hypermellose (Tablet C)
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study)
Hepatitis B virus (HBV) remains a major global health problem with an estimated 257 million people living with the infection worldwide. Chronic HBV (CHB) is a major cause of liver cirrhosis and hepatocellular carcinoma.
- Trial name
- SAMBA (NCT06668727)
- Testing
- HepB mAb19
- Where
- Denmark
- Volunteers
- 30 people
- Sponsor
- Aarhus University Hospital
Solid Tumor, Metastatic Tumor
A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors
A Phase 1 dose escalation study to determine if axatilimab as monotherapy and axatilimab in combination with a fixed dose of durvalumab will be sufficiently safe and well-tolerated at biologically active doses to warrant further…
- Conditions
- Solid Tumor, Metastatic Tumor, Locally Advanced Malignant Neoplasm, Unresectable Malignant Neoplasm
- Trial name
- NCT03238027
- Testing
- Axatilimab, Durvalumab
- Where
- 5 sites in United States
- Volunteers
- 45 people
- Sponsor
- Syndax Pharmaceuticals
Trypanosomiasis, Trypanosomiasis, African
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158
This study is aimed at assessing the tolerability and pharmacokinetic parameters of SCYX-7158 in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, SCYX-7158 shows highly…
- Conditions
- Trypanosomiasis, Trypanosomiasis, African, Protozoan Infections, Parasitic Diseases
- Trial name
- NCT01533961
- Testing
- SCYX-7158
- Where
- 2 sites in France
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
EC905, Pharmacokinetics
A Study to Evaluate Whether Food Has an Effect on the Uptake of Solifenacin and Tamsulosin When Administered in a Combination Tablet
To evaluate the effect of food (low and high fat breakfast vs. fasting) on the pharmacokinetics (what the body does to the drug) of a single dose of solifenacin and tamsulosin administered as combination tablet EC905.
- Conditions
- EC905, Pharmacokinetics, Healthy Subjects
- Trial name
- NCT01953861
- Testing
- EC905
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Healthy
AV650 Drug-Drug Interaction Study
The purpose of this study is to evaluate the effects that paroxetine and fluvoxamine have on the way the body distributes, breakdowns and eliminates AV650.
- Trial name
- NCT00456560
- Testing
- AV650, Fluvoxamine, Paroxetine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Avigen
Hepatic Impairment
Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment
This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI), and in matched healthy control subjects with…
- Trial name
- NCT04573582
- Testing
- Enasidenib
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Celgene
Healthy Volunteers, Asthma
Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals
RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending dose(s) of RP3128 in healthy…
- Trial name
- NCT02958982
- Testing
- RP3128
- Where
- Canada
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Rhizen Pharmaceuticals SA
Coronavirus Disease 2019, Coronavirus Disease 2019 (COVID-19)
A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir
Healthy adults will be enrolled into this open-label, Phase 1 research study. Participants will spend about 9 nights and 10 days in the clinical research unit (CRU) and the total time in the study will be about 11 weeks.
- Conditions
- Coronavirus Disease 2019, Coronavirus Disease 2019 (COVID-19), COVID-19 (Coronavirus Disease 2019), Upper Respiratory Tract Infections
- Trial name
- NCT07552779
- Testing
- Ibuzatrelvir co-process API film coated tablet, Ibuzatrelvir filmcoated tablet
- Where
- Belgium
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tobacco Dependence
Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.
- Trial name
- NCT01234896
- Testing
- Nicotine Medicated Gum, 4 mg Nicotine Gum, 2 mg Nicotine Gum
- Where
- Sweden
- Volunteers
- 44 people
- Sponsor
- McNeil AB
Healthy
Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions
The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fed conditions…
- Trial name
- NCT01581788
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Live Attenuated Influenza Vaccine
A Phase III/IV Open-label Study of the Immunogenicity and Safety of a Single Dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for Each of Three Successive Years in Children naïve to, or in Previous Receipt of the AS03B Adjuvanted H1N1 (2009) Influenza Vaccine (Pandemrix ™).
The Department of Health has recently announced the implementation of annual vaccination for all those aged 18 years and under, with live attenuated influenza vaccine (LAIV), which is delivered as a nasal spray.
- Trial name
- LAIV Immuno (NCT02143882)
- Testing
- Fluenz
- Where
- 2 sites in United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Public Health England
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