Clinical trials: Phase 1
Healthy Volunteers
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects
Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs.
- Trial name
- NCT02963701
- Testing
- Ibuprofen, Pseudoephedrine-HCl
- Where
- South Africa
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Sjogren Syndrome, Malignant Tumors
The Feasibility of Multispectral Optoacoustic Tomography in Different Diseases
Optoacoustic imaging is a new and innovative imaging technique that combines the high contrast of optical imaging with the penetration depth and high spatial resolution of ultrasonography using the optoacoustic effect.
- Conditions
- Sjogren Syndrome, Malignant Tumors, Arterial Disease
- Trial name
- FOMO (NCT06740175)
- Testing
- Multispectral optoacoustic tomography
- Where
- Netherlands
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Medical Center Groningen
Healthy Volunteer
A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers
This open-label, two-arm, drug interaction study will investigate the effect of co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy volunteers.
- Trial name
- NCT01814709
- Testing
- GDC-0032, Itraconazole, Rifampin
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Bacterial Infections
Drug-Drug Interaction Study of IV QPX2014 Combined With QPX7728 in Healthy Adult Subjects
QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous beta-lactamases, including class A extended spectrum betalactamases (ESBLs), class C cephalosporinases, and extended spectrum class D…
- Trial name
- NCT05072444
- Testing
- QPX7728, QPX2014
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Erectile Dysfunction, Pulmonary Arterial Hypertension
Study of the Pharmacokinetics and Safety of TPN171H Tablets in Subjects With Mild ,Moderate Hepatic Insufficiency and Normal Liver Function
The study aims to investigate and compare the effect of TPN171H on subjects with mild and moderate hepatic impairment compared to healthy subjects.
- Trial name
- NCT05185011
- Testing
- TPN171H
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Group B Streptococcal Infections
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
- Trial name
- NCT06611371
- Testing
- IVT GBS-06
- Where
- 2 sites in United States, South Africa
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Hepatic Impairment
EVP-6124 Hepatic Impairment Study
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT01984736
- Testing
- Experimental: EVP-6124
- Where
- 3 sites in Czechia, Poland and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- FORUM Pharmaceuticals Inc
Healthy
A Study of Elpipodect (MK-8189) Human Absorption, Metabolism, and Excretion in Healthy Male Participants (MK-8189-010)
The purpose of this study is to learn what happens to elpipodect in a healthy person's body over time.
- Trial name
- NCT06626464
- Testing
- [14C]Elpipodect
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects
This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single…
- Trial name
- NCT03135509
- Testing
- CC-220
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Celgene
Respiratory Syncytial Virus Infections
Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children.
- Trial name
- NCT02237209
- Testing
- RSV LID ΔM2-2 Vaccine
- Where
- 7 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Peritoneal Carcinomatosis, Peritoneal Metastases
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.
- Conditions
- Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Gastric Cancer
- Trial name
- NCT03682744
- Testing
- anti-CEA CAR-T cells
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sorrento Therapeutics, Inc.
Traumatic Brain Injury (TBI)
A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers
- Trial name
- NCT05033444
- Testing
- PRV-002
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Odyssey Group International, Inc.
Chronic Obstructive Pulmonary Disease (COPD)
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential.
- Trial name
- NCT01754844
- Testing
- AZD7624
- Where
- United Kingdom
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.
The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (what the body does to a medication) of GSK2336805 alone and with the co-administration of TMC435 in healthy Japanese participants.
- Trial name
- NCT02018536
- Testing
- GSK2336805 30 mg, GSK2336805 60 mg, GSK2336805 120 mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Healthy Participants
A Study to Evaluate the Bioequivalence Between Immediate Release Tablets and Minitablets of Deucravacitinib (BMS-986165), and the Effect of Food and pH on the Drug Levels of the Minitablets in Healthy Adults
The purpose of this study is to evaluate the bioequivalence between immediate release tablets and minitablets of Deucravacitinib (BMS-986165), and the effect of food and pH on the drug levels of the minitablets in healthy adults.
- Trial name
- NCT06851871
- Testing
- Deucravacitinib, Famotidine
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Participants
Evaluate the Effect of Vimseltinib on Organic Cation Transporter 2 (OCT2)
The main purpose of this study is to evaluate the effect of multiple doses of vimseltinib on the pharmacokinetics (PK) of a clinical OCT2 substrate (metformin) in healthy male participants.
- Trial name
- NCT07158411
- Testing
- Vimseltinib, Metformin
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Deciphera Pharmaceuticals, LLC
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
- Trial name
- NCT05481411
- Testing
- Olpasiran
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Amgen
Opioid Induced Constipation
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
- Trial name
- NCT01623609
- Testing
- Naloxegol
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Male Volunteers
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test | Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN to somatrogon in VIAL…
- Trial name
- NCT03810664
- Testing
- Somatrogon
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Renal Insufficiency
PK Study of ACHN-490 Injection in Renally Impaired Subjects
The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection.
- Trial name
- NCT01462136
- Testing
- ACHN-490 Injection
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Achaogen, Inc.
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