Clinical trials: Phase 1
Healthy
Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292
This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics…
- Trial name
- NCT01692184
- Testing
- 50 mg AVL-292, 100 mg AVL-292, 200 mg AVL-292
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Celgene
Malaria
G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)
SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and Medicines for Malaria Venture (MMV).
- Trial name
- NCT01205178
- Testing
- Chloroquine, Primaquine, Tafenoquine
- Where
- 2 sites in Thailand
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Pain
Study To Assess Safety, Tolerability And PK Of ATB-346 In Healthy Subjects
A double-blind, placebo-controlled, phase I study to assess safety, tolerability and pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy male and female subjects.
- Trial name
- NCT03220633
- Testing
- ATB-346
- Where
- Canada
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Antibe Therapeutics Inc.
Healthy Volunteer
Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects
The study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days in order to allow for including Japanese subjects in…
- Trial name
- NCT02176252
- Testing
- AZD1722
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Ardelyx
Avian Influenza, Bird Flu
Safety Study of an Oral Vaccine to Prevent Avian Influenza
The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.
- Trial name
- H5N1 (NCT01335347)
- Testing
- ND1.1
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Vaxart
Healthy
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
- Trial name
- NCT02174835
- Testing
- AVP-786, AVP-923
- Where
- Australia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyperammonemia
A Healthy Volunteer Study to Compare Fezagepras (PBI-4050) With Sodium Phenylbutyrate
The purpose of this study is to compare the safety, tolerability and pharmacokinetic profile of fezagepras (PBI-4050) to that of sodium phenylbutyrate (PBA) when both products are given as single ascending doses to healthy adult…
- Trial name
- NCT05349435
- Testing
- Fezagepras, Sodium phenylbutyrate
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Liminal BioSciences Ltd.
Type 2 Diabetes Mellitus (T2DM)
A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males
This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design.
- Trial name
- NCT07630233
- Testing
- UBT38006, Insulin Degludec Injection, Insulin Icodec Injection
- Where
- China
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
Vaccine-Preventable Diseases, Herpes Zoster
Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above
The purpose of this study is to evaluate the safety and immunogenicity of the investigational medicinal product, CVI-VZV-001.
- Trial name
- NCT06137755
- Testing
- CVI-VZV-001, Shingrix
- Where
- 2 sites in South Korea
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Aribio Lab Co., Ltd.
Healthy Adult Subjects
Effect of Cimetidine on the Single-Dose PK of IV- Administered MNTX
This open-label study assesses the single-dose pharmacokinetics of intravenously-administered MNTX in healthy adult male and female subjects in the absence of, and in the presence of, orally-administered cimetidine.
- Trial name
- NCT01366378
- Testing
- methylnaltrexone
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Diabetes Mellitus
Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects
Primary Objective: To assess the effect of multiple dose mefenamic acid on the pharmacokinetics (PK) of sotagliflozin and its metabolite in healthy male and female subjects.
- Trial name
- NCT03070678
- Testing
- Sotagliflozin (SAR439954), Mefenamic acid
- Where
- France
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sanofi
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.
Bioequivalence
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe…
- Trial name
- NCT05817435
- Testing
- efgartigimod PH20 SC as a prefilled syringe presentation, efgartigimod PH20 SC as a vial + syringe presentation
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy
An Open-Label Food Effect Study of Telotristat Etiprate
This study is designed to evaluate the effect of food on the pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to administration of single dose telotristat etiprate in the fasted state in healthy…
- Trial name
- NCT02157584
- Testing
- Telotristat etiprate
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Healthy
A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses of REGN7999 in healthy adult participants.
- Trial name
- NCT05481333
- Testing
- REGN7999
- Where
- Belgium
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
HIV Infections
A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels
IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal…
- Trial name
- NCT00613249
- Testing
- Dapivirine Gel 4750, 0.05%, 2.5g, Dapivirine Gel 4789, 0.05%, 2.5g
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Healthy Adults
A Study to Learn About How the Study Medicines Called Itraconazole and Probenecid Change How the Body Processes PF-07220060
The purpose of the study is to see and learn the effect of multiple doses of a strong CYP3A4 inhibitor and a potent UGT2B7 inhibitor on the PK of PF-07220060.
- Trial name
- NCT07160738
- Testing
- PF-07220060, Itraconazole, Probenecid
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subjects
Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
Part 1 of the study will be conducted to provide additional information on the safety and tolerability of single doses of BOS172767 in healthy participants, to evaluate the pharmacokinetic (PK) profiles (including relative…
- Trial name
- NCT03464058
- Testing
- BOS172767 tablets, BOS172767 liquid capsules, BOS172767 micronized capsules
- Where
- United Kingdom
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Pharmaceuticals
Healthy Volunteers
A Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy Participants
The primary objective of this study is to determine the relative bioavailability of treprostinil (TRE) between the TPIP F2 and TPIP F3 at 3 capsule strengths, dose A, dose B, and dose C, in healthy participants following a single…
- Trial name
- NCT07102316
- Testing
- TPIP F2, TPIP F3
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Insmed Incorporated
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.
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