Clinical trials: Phase 1
Healthy Participants
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus®
Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS Glargine (G), United States (US)-Lantus®, and…
- Trial name
- NCT06627478
- Testing
- NKF-INS(G), US-Lantus®, EU-Lantus®
- Where
- South Africa
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Xentria, Inc.
Atopic Dermatitis
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
- Trial name
- NCT06268860
- Testing
- Rocatinlimab vial injection, Rocatinlimab prefilled syringe
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy, Renal Impairment
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood.
- Trial name
- NCT06643377
- Testing
- Enlicitide
- Where
- 5 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants
The primary objective of this study was to assess the effect of a cytochrome P450 3A4 (CYP3A4) inhibitor (itraconazole) and CYP3A4 inducer (carbamazepine) on the single dose pharmacokinetics (PK) of DC-806 coadministered with…
- Trial name
- NCT05994807
- Testing
- DC-806, Itraconazole, Carbamazepine
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Healthy, Obesity, Metabolically
A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities.
- Trial name
- NCT05378893
- Testing
- DR10624 for injection
- Where
- New Zealand
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
Healthy Participants
A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants
The main objective of this study is to assess the effect of DC-806 on the pharmacokinetics (PK) of cytochrome 3A4 (CYP3A4) substrate, midazolam and its active metabolite, 1-hydroxymidazolam, cytochrome 2C8 (CYP2C8) substrate…
- Trial name
- NCT06092931
- Testing
- DC-806, Midazolam, Repaglinide
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Renal Impairment
A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218
The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are…
- Trial name
- NCT05844228
- Testing
- VIR-2218
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Smoking, Cigarette
Biomarkers of Exposure and Effect in Standardized Research E-cigarette (SREC) Users
This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National Institute on Drug Abuse.
- Trial name
- NCT04003805
- Testing
- Standardized Research E-cigarette (SREC)
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Masonic Cancer Center, University of Minnesota
Obesity, Type2diabetes
The Effects of Glucagon on Hepatic Metabolism
Whether impaired postprandial glucagon suppression in prediabetes and T2DM is an attempt to overcome resistance to glucagon's actions on hepatic AA catabolism, a defect in α-cell function, or a combination of both are important…
- Conditions
- Obesity, Type2diabetes, NAFLD
- Trial name
- NCT05500586
- Testing
- Glucagon response study
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Adrian Vella
Hepatitis B
Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy…
- Trial name
- NCT05330455
- Testing
- GSK3965193, Bepirovirsen
- Where
- 14 sites in Canada, France and 4 more
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy, Dermatitis, Atopic
A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis
The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis (AtD).
- Trial name
- NCT05486208
- Testing
- LY3844583
- Where
- 3 sites in United States, Japan
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Cerebral Palsy
Telehealth Virtual Reality Gaming on Cardiometabolic Health Among Youth With Cerebral Palsy
The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group.
- Trial name
- NCT05336227
- Testing
- Virtual Reality Exergaming
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Bacterial Vaginosis
A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis
This was a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed…
- Trial name
- NCT06469164
- Testing
- BNT331
- Where
- 6 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Adrenal Insufficiency
An Investigational Study of Hydrocortisone
This study will investigate a new drug called Infacort®; a newly-developed immediate release formulation of a well-established drug called hydrocortisone.
- Trial name
- NCT01960530
- Testing
- Hydrocortisone granules, Hydrocortisone Tablet, i.v. Hydrocortisone Injection
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Neurocrine UK Limited
Healthy Adult Subjects
A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
- Trial name
- Willow 1 (NCT03267732)
- Testing
- Pegilodecakin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Relative Bioavailability of a Single Oral Dose of BI 425809 When Administered Alone or in Combination With Multiple Oral Doses of Itraconazole in Healthy Male Subjects
To investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI 425809 in healthy male subjects
- Trial name
- NCT02342717
- Testing
- BI 425809, Itraconazole
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Subjects
Comparison of Pharmacokinetics of Infacort® Versus Immediate-release Hydrocortisone
This was a single centre, open-label, randomised, 5-way crossover study.
- Trial name
- NCT02777268
- Testing
- Infacort, Hydrocortisone
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Neurocrine UK Limited
Healthy
Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
- Trial name
- SIGA-246-002 (NCT00431951)
- Testing
- ST-246
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
Malaria
L9LS MAb in Malian Infants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of L9LS in infants in Mali and to evaluate the impact of L9LS on subsequent R21/Matrix-MTM vaccine immunogenicity.
- Trial name
- NCT06461026
- Testing
- L9LS, R21/Matrix-MTM
- Where
- 3 sites in Mali
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Orthopoxviral Disease, Smallpox
Phase I Trial of an Investigational Small Pox Medication
The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
- Conditions
- Orthopoxviral Disease, Smallpox, Monkey Pox
- Trial name
- NCT00728689
- Testing
- ST-246 Days 1 - 3, ST-246 Days 11 - 13
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
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