Clinical trials: Phase I
Drug Overdose, Opioid-Related Disorders
Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable…
- Trial name
- NCT02572089
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute on Drug Abuse (NIDA)
Phase 1 Study, Healthy Volunteers
Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.
- Trial name
- NCT05149274
- Testing
- DWP14012 Tablet A, DWP14012 Tablet B
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
A Study to Examine the Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of TMC435 in Healthy Chinese Participants
The purpose of this study is to determine the pharmacokinetics (what the body does to a medication) of TMC435 after multiple oral doses of 100 and 150 mg TMC435 once daily for 7 days in healthy Chinese participants.
- Trial name
- NCT02071355
- Testing
- TMC435 100 mg, TMC435 150 mg
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment
A Single Dose Study of Oral Vadadustat in Subjects With Normal and Impaired Hepatic Function
This is a Phase I open-label study to evaluate the pharmacokinetic (PK) profile of a single oral dose of vadadustat in subjects with hepatic impairment(HI) compared to healthy matched control subjects with normal hepatic function.
- Trial name
- NCT03799848
- Testing
- Vadadustat
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Healthy Volunteer Study
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Ethinyl Estradiol/Levonorgestrel (EE/LNG)
Drug-drug interaction study between Ethinyl Estradioll/Levonorgestrel and Bemnifosbuvir/Ruzasvir
- Trial name
- NCT07272889
- Testing
- Ethinyl Estradioll/Levonorgestrel (EE/LNG), Bemnifosbuvir/Ruzasvir (BEM/RZR), Bemnifosbuvir/Ruzasvir (BEM/RZR) + Ethinyl Estradioll/Levonorgestrel (EE/LNG)
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Healthy Participants
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Single-dose Adagrasib (BMS-986503) in Healthy Participants of Japanese Descent
The aim of this study is to assess the pharmacokinetics, safety and tolerability of single-dose Adagrasib (BMS-986503) in healthy participants of Japanese descent
- Trial name
- NCT07723118
- Testing
- Adagrasib
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Mirati Therapeutics Inc.
Healthy
A Study of JNJ-64251330 in Healthy Participants
The purpose of this study is to evaluate: systemic and local gut (rectum and sigmoid colon) exposure to JNJ-64251330, local tissue Pharmacodynamics (PD) using gut (rectum and sigmoid colon) biopsies (Part 1) and the effect of…
- Trial name
- NCT04552197
- Testing
- JNJ-64251330, Tofacitinib
- Where
- Belgium
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Drug Interactions
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen
The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of…
- Trial name
- NCT03324685
- Testing
- BIIB074, OC (ethinyl estradiol and levonorgestrel)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Biogen
Adolescent Behavior, Adolescent - Emotional Problem
Family-Focused Adolescent & Lifelong Health Promotion
The aim of this study is to adapt the Parenting for Lifelong Health for Parents and Teens (PLH) with the Helping Adolescents Thrive Comics in North Macedonia and the Republic of Moldova and conduct a pilot feasibility study of…
- Conditions
- Adolescent Behavior, Adolescent - Emotional Problem, Psychological Well-Being, Parent-Child Relations
- Trial name
- FLOURISH (NCT05930535)
- Testing
- Parenting for Lifelong Health for Parents and Teens
- Where
- 2 sites in Moldova, North Macedonia
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- University of Klagenfurt
Healthy
A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food
This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations.
- Trial name
- NCT02534740
- Testing
- tafamidis
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Drug Abuse, Healthy
Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214
This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to placebo, ketamine, and phentermine in healthy recreational polydrug users.
- Trial name
- TC-5214 (NCT01500018)
- Testing
- TC-5214, Ketamine, Phentermine
- Volunteers
- healthy volunteers welcome
- Sponsor
- AstraZeneca
Bacterial Infections
To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100
Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the pharmacokinetics of BV100 in healthy volunteers.
- Trial name
- NCT05684718
- Testing
- BV100 (300 mg), Itraconazole 200 mg
- Where
- Hungary
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- BioVersys AG
Dry Eye Syndromes
Lifitegrast Eye Drops in Healthy Subjects：Phase I Study
This is a single-center, randomized, double-blind, single-dose, two-period crossover Phase I clinical trial designed to: Compare the pharmacokinetic (PK) profiles of Lifitegrast Ophthalmic Solution and Xiidra® in plasma and tears…
- Trial name
- NCT07040826
- Testing
- Xiidra, Lifitegrast
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy
A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects
The purpose of this study is to compare drug blood levels of multiple formulations of inhaled PUR0200 to each other and to the reference product with and without oral charcoal.
- Trial name
- NCT02671825
- Testing
- PUR0200, Reference Product
- Where
- Bulgaria
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pulmatrix Inc.
Anthrax
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at…
- Trial name
- NCT00057525
- Testing
- Anthrax, Alhdryogel or PBS
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- DynPort Vaccine Company LLC, A GDIT Company
Dengue
Evaluating the Safety and Effectiveness of a Dengue Virus Vaccine in Healthy Adults
Dengue viruses can cause dengue illness ranging from a mild illness to life-threatening disease. The purpose of this study is to evaluate the protective effectiveness of a dengue virus vaccine in healthy adults.
- Trial name
- NCT02021968
- Testing
- TetraVax-DV-TV003, rDEN2∆30-7169
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Renal Impairment, Healthy
Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function
The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of…
- Trial name
- NCT02647918
- Testing
- Sotagliflozin
- Where
- 4 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Healthy Subjects
A Study to Assess Ulimorelin in Healthy Subjects
A Phase I dose escalation study involving healthy subjects.
- Trial name
- NCT02993055
- Testing
- Ulimorelin
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Lyric Pharmaceuticals
ABBV-154
Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants
This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.
- Trial name
- NCT05556226
- Testing
- ABBV-154 Dose Formulation A, ABBV-154 Dose Formulation B
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy
A Bioavailability Study Comparing 3 Different AZD1981 Tablets
The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.
- Trial name
- NCT01311635
- Testing
- AZD1981, current small-particle tablet, AZD1981, new small-particle tablet, AZD1981, new large-particle table
- Where
- Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
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