Clinical trials: Single Dose
End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD)
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal…
- Conditions
- End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD), Kidney Failure, Chronic
- Trial name
- NCT05769595
- Testing
- MK-2060
- Where
- 12 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)
This study is being performed to evaluate a single 60 Mcg dose of lyophilized formulation of Merck Staphylococcus aureus vaccine (V710) in healthy subjects.
- Trial name
- NCT00822757
- Testing
- Comparator: V710
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Migraine Headache, Aura
Staccato Prochlorperazine in Migraine (Out Patient)
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients…
- Trial name
- NCT00422812
- Testing
- Inhaled PCZ 5 mg, Inhaled PCZ 7.5 mg, Inhaled PCZ 10 mg
- Where
- 25 sites in United States
- Volunteers
- 400 people
- Sponsor
- Alexza Pharmaceuticals, Inc.
HIV Infections
Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV
A single dose of nevirapine (SD NVP) given to an HIV infected pregnant woman followed by a single dose to her infant has been shown to be an effective way of reducing the risk of mother-to-child transmission (MTCT) of HIV.
- Trial name
- P1060 (NCT00307151)
- Testing
- Lamivudine, Lopinavir/ritonavir, Nevirapine
- Where
- 10 sites in India, Malawi and 5 more
- Volunteers
- 452 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Duchenne Muscular Dystrophy
A Study to Evaluate the Safety and Tolerability of PF-06939926 Gene Therapy in Duchenne Muscular Dystrophy
This is a first-in-human/first-in-patient, multi-center, open-label, non-randomized, ascending dose, safety and tolerability study of a single intravenous infusion of PF-06939926 in ambulatory and non-ambulatory subjects with…
- Trial name
- NCT03362502
- Testing
- PF-06939926
- Where
- 22 sites in United States
- Volunteers
- 23 people
- Sponsor
- Pfizer
Postoperative Nausea and Vomiting
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in…
- Trial name
- NCT01395901
- Testing
- Palonosetron, Ondansetron
- Where
- 44 sites in United States, Argentina and 6 more
- Volunteers
- 670 people
- Sponsor
- Helsinn Healthcare SA
Safety, Tolerability
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects
The purpose of this study is to test the safety and observe the pharmacokinetics (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy male subjects following a single oral dose.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Cancer
- Trial name
- NCT02054754
- Testing
- Dexanabinol Dose Level 1, Dexanabinol Dose Level 2, Dexanabinol Dose Level 3
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- e-Therapeutics PLC
Postoperative Retention of Urine
Effect of Preoperative Tamsulosin on Postoperative Urinary Retention
Approximately 25-30% of patients experience postoperative urinary retention after female pelvic surgery with mid-urethral sling placement. These patients are discharged home with a foley catheter for a few days.
- Trial name
- NCT05753670
- Testing
- Tamsulosin
- Where
- United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Endeavor Health
Schizophrenia
A Study to Determine the Maximum Tolerated Dose of an Investigational Drug in Subjects With Schizophrenia
A study to determine the maximum tolerated dose of an investigational drug in subjects with schizophrenia
- Trial name
- NCT03627195
- Testing
- DSP-1349M
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Sumitomo Pharma America, Inc.
Hypogonadism
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection…
- Trial name
- NCT03792477
- Testing
- Test formulation, Reference formulation
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pfizer
Methemoglobinemia, Congenital Methemoglobinemia
Safety, Tolerability, and Pharmacokinetic Study of Methylene Blue Following a 1 mg/kg Intravenous Dose in Healthy Adults
A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of Methylene Blue Injection, USP 1 mg/kg in healthy adult volunteers.
- Trial name
- NCT02478281
- Testing
- Methylene Blue
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- American Regent, Inc.
Participants Less Than 12 Months of Age With RSV Illness
A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness
This was a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to determine the effect of a single 30 mg/kg intramuscular (IM) dose of motavizumab on viral load and motavizumab levels in the upper respiratory…
- Trial name
- NCT00435227
- Testing
- Motavizumab
- Where
- 31 sites in United States
- Volunteers
- 12 people
- Sponsor
- MedImmune LLC
Orthopoxviral Disease
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers.
- Trial name
- 246-Safety (NCT00907803)
- Testing
- ST-246 400 mg, ST-246 600 mg
- Where
- 3 sites in United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Escherichia Coli Diarrhea
Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh
The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.
- Trial name
- ETVAX/dmLT (NCT02531802)
- Testing
- ETVAX, dmLT, Bicarbonate Buffer
- Where
- Bangladesh
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- PATH
Pulmonary Arterial Hypertension
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (>=)…
- Trial name
- NCT03492177
- Testing
- selexipag (Uptravi)
- Where
- 34 sites in United States, Belarus and 14 more
- Volunteers
- 63 people
- Sponsor
- Actelion
Chronic Lymphocytic Leukemia
Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control.
- Trial name
- NCT01539291
- Testing
- Idelalisib
- Where
- 45 sites in United States, France and 3 more
- Volunteers
- 161 people
- Sponsor
- Gilead Sciences
Migraine
Staccato Loxapine in Migraine (in Clinic)
The objective of this trial is to assess the efficacy and safety of Staccato Loxapine in patients with migraine headache with or without aura in a clinical setting.
- Trial name
- NCT00489476
- Testing
- Staccato Loxapine
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Alexza Pharmaceuticals, Inc.
Uncomplicated Plasmodium Falciparum Malaria
Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.
A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients > 0.5 years and <= 70 years of age with…
- Trial name
- NCT02083380
- Testing
- Artefenomel 800mg: piperaquine 640mg, Artefenomel 800mg: piperaquine 960mg, Artefenomel 800mg: piperaquine 1440mg
- Where
- 9 sites in Benin, Burkina Faso and 5 more
- Volunteers
- 448 people
- Sponsor
- Medicines for Malaria Venture
Healthy
Comparison of the Bioavailability of Diclofenac in a Combination Product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) With Two Diclofenac Only Products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel, in Healthy Volunteers
The main objective of this study is to assess the relative systemic bioavailability of diclofenac in the presence and absence of capsaicin by comparing the systemic bioavailability of diclofenac from a combination product…
- Trial name
- NCT03074162
- Testing
- Diclofenac Sodium, Diclofenac & Capsaicin, Diclofenac Sodium Topical Gel
- Where
- South Africa
- Volunteers
- 48 people
- Sponsor
- Boehringer Ingelheim
Migraine Disorders
Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)
Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of…
- Trial name
- NCT00701389
- Testing
- telcagepant potassium, sumatriptan
- Volunteers
- 24 people
- Sponsor
- Merck Sharp & Dohme LLC
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