Clinical trials: Phase I
Hepatic Impairment
Study of Nalbuphine ER in Participants With Hepatic Impairment
This research study will evaluate the effect of hepatic impairment on the pharmacokinetics (the breakdown of the drug in the body) of parallel-group, multiple oral doses nalbuphine extended release (NAL ER), tablets in people…
- Trial name
- NCT04020016
- Testing
- Nalbuphine ER
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Trevi Therapeutics
Healthy
RDEA3170 AME Study
This study will determine the characteristics of absorption, metabolism, and excretion (AME) of RDEA3170 following a single 10 mg dose of RDEA3170 oral solution with 500 microcuries (µCi) of [14 C]RDEA3170 in healthy adult male…
- Trial name
- NCT01910506
- Testing
- RDEA3170 10 mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Healthy
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects
A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects
- Trial name
- NCT04250506
- Testing
- Daridorexant, Moxifloxacin
- Where
- Czechia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy
Human Repeated Insult Patch Test (HRIPT) of Azelaic Acid Pre Foam Formulation
The purpose of this study is to determine the dermal sensitization potential of azelaic acid pre-foam formulation.
- Trial name
- NCT01430533
- Testing
- azelaic acid pre foam formulation, Vehicle pre foam formulation, Water
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- LEO Pharma
Healthy
Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg and 100 μg Clonidine and comparative bioavailability of clonidine with that from the Reference drug, Catapres® 100 μg oral tablets…
- Trial name
- NCT02548806
- Testing
- Clonidine MBT 50µg, Clonidine MBT 100µg, Catapres 100μg
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valerio Therapeutics
Healthy
Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers
Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.
- Trial name
- NCT02477449
- Testing
- istaroxime, 9% Saline (NS)
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Duchenne Muscular Dystrophy (DMD)
A Trial to Investigate the Safety and Pharmacokinetics of GRT6019 in Healthy Male Participants
The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants. This Phase I trial will be a multiple dose trial in healthy male participants with administration of…
- Trial name
- NCT07347548
- Testing
- GRT6019
- Where
- France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Hepatic Impairment
MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
This study is a phase I, multi-center, open-label, single oral dose, parallel group study to assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- MEK162 (NCT02050815)
- Testing
- MEK162
- Where
- 5 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Autoimmune Diseases, Multiple Sclerosis
First-in-Human Trial in Healthy Adult Volunteers to Evaluate Safety, Tolerability and PK of LAPIX Study Drug; LPX-TI641
A Phase I First-in-Human, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adult Volunteers to Evaluate Safety, Tolerability, and Pharmacokinetics after Single and Multiple Oral Dose of LPX-TI641.
- Trial name
- NCT05853835
- Testing
- LPX-TI641
- Where
- 2 sites in United States, Jordan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- LAPIX Therapeutics Inc.
Helicobacter Pylori Infection
The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets
A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in…
- Trial name
- NCT06337604
- Testing
- TNP-2092 capsules, Rabeprazole sodium enteric-coated tablets
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics Inc.
Healthy Volunteer
Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects
Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.
- Trial name
- NCT05508204
- Testing
- BION-1301
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chinook Therapeutics, Inc.
Healthy
A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects
- Trial name
- NCT03907215
- Testing
- ACT541468, Citalopram
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy
Safety, Tolerability and Pharmacokinetics of NTP42:KVA4
A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial.
- Trial name
- NCT04919863
- Testing
- NTP42:KVA4
- Where
- United Kingdom
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- ATXA Therapeutics Limited
Chronic Obstructive Pulmonary Disease
A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant
The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) [Test] and hydrofluoroalkane…
- Trial name
- NCT05569421
- Testing
- Treatment A: BGF MDI HFO, Treatment B: BGF MDI HFA
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Subjects
UP-818-CC Injection in Healthy Chinese Subjects
The objectives of this study are to evaluate the safety, tolerability and pharmacokinetic characteristics in healthy Chinese volunteers after single and multiple dose of intravenous infusion of UP-818-CC.
- Trial name
- UP-818-CC (NCT07355621)
- Testing
- UP-818-CC injection
- Where
- China
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- EnliTISA (Shanghai) Pharmaceutical Co., Ltd.
Healthy Adult
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901
To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901
- Trial name
- NCT06171880
- Testing
- JLP-1901, JC-001(active comparator)
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jeil Pharmaceutical Co., Ltd.
Lidocaine Adverse Reaction, Prilocaine Adverse Reaction
Efficacy of a Topical Anesthetic Containing Lidocaine and Prilocaine in Treatment With CO2 Fractional Laser
This is a study aimed at evaluating the efficacy of a topical anesthesia (test product) compared to placebo in adult patients of phototypes I to III, with indication of treatment of CO2 fractional laser in the forehead.
- Trial name
- CO2 (NCT03366246)
- Testing
- Lidocaine / Prilocaine Cream
- Where
- Brazil
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Galeno Desenvolvimento de Pesquisas Clínicas
Dengue
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults
Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety and immune response to the dengue vaccine…
- Trial name
- NCT00322946
- Testing
- rDEN4delta30-4995
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Mild Atopic Asthma
A Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of BITS7201A in Healthy Volunteers and Participants With Mild Atopic Asthma
This randomized, observer-blinded, placebo-controlled, single and multiple ascending-dose study will be conducted in two parts to evaluate the safety, pharmacokinetics, and immunogenicity of BITS7201A.
- Trial name
- NCT02748642
- Testing
- BITS7201A
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
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