Clinical trials: Healthy Japanese
Healthy Subjects
A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
- Trial name
- NCT03586570
- Testing
- Aprocitentan 25mg
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to…
- Trial name
- NCT02821858
- Testing
- Odalasvir (ODV), AL-335
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Adult Male
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815. To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815 To assess…
- Trial name
- NCT04182958
- Testing
- (14C)-OPC-61815
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Healthy Volunteers
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
This is a phase 1 study in otherwise healthy participants with high LDL cholesterol. Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body…
- Trial name
- NCT01618916
- Testing
- LY3015014
- Where
- 2 sites in United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Study of JNJ-77242113 in Healthy Japanese and Chinese Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-77242113 after single ascending oral dose administration as an immediate-release (IR) tablet formulation in healthy Japanese…
- Trial name
- NCT05062200
- Testing
- JNJ-77242113
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Infections, Bacterial
A Three-part Study to Determine the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Volunteers and Healthy Male Japanese Subjects
The primary objectives of this study are to assess the safety, tolerability and pharmacokinetics of GSK1322322 following intravenous (IV) and oral administration.
- Trial name
- NCT01818011
- Testing
- GSK1322322 Initial fit for purpose tablets, GSK1322322 over granulated tablets, GSK1322322 intended commercial tablets
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers
This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days…
- Trial name
- NCT02066909
- Testing
- 0.15 mg PF-06649751, 0.5 mg PF-06649751, 1.5 mg PF-06649751
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Adult
A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods…
- Trial name
- NCT01506752
- Testing
- Donepezil Hydrochloride
- Where
- Japan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2831781 After an Intravenous (IV) Dose in Healthy Japanese and Caucasian Subjects, and a Subcutaneous (SC) Dose in Healthy Caucasian Subjects
This is a double-blind, placebo-controlled, randomized, parallel group, two-part study where single IV doses of GSK2831781 will be administered to healthy Japanese and Caucasian subjects in part A and SC doses will be…
- Trial name
- NCT03965533
- Testing
- GSK2831781
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Edema
Xerecept Intravenous Dose Escalation in Japanese and Caucasian Volunteers
1. To investigate the safety and tolerability of Xerecept during and following a 24-hour intravenous administration to healthy Japanese to healthy Japanese and Caucasian subjects 2.
- Trial name
- NCT00820092
- Testing
- Xerecept 1.0, Xerecept 2.0, Xerecept 3.0
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Celtic Pharma Development Services
Hereditary Angioedema
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and…
- Trial name
- NCT02448264
- Testing
- BCX7353
- Where
- United Kingdom
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Healthy
A Study of LY3473329 in Healthy Japanese Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in healthy Japanese participants. The study will also assess how fast LY3473329 gets into the blood stream and how long it takes the body to…
- Trial name
- NCT05038787
- Testing
- LY3473329
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Infection, Human Immunodeficiency Virus
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects
This study is a Phase 1, open label, non-randomized, single dose study to determine pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral administration in healthy Japanese subjects.
- Trial name
- NCT01332565
- Testing
- GSK1349572
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Osteopenia
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese…
- Trial name
- NCT01101061
- Testing
- Romosozumab
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteer
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers
This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50, mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers.
- Trial name
- NCT01299298
- Testing
- mipomersen
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Kastle Therapeutics, LLC
Diabetic Neuropathic Pain, Healthy Volunteers
A Study to Learn How Safe the Study Treatment BAY2395840 is, How it Affects the Body and How it Moves Into, Through, and Out of the Body if Given in Single and in Repetitive Doses to Japanese Healthy Male Participants
Researchers are looking for a better way to treat people who have diabetic neuropathic pain (DNP). DNP is pain due to damage to the nerves in the extremities that can occur in patients with diabetes as a result of blood sugar…
- Trial name
- NCT05563454
- Testing
- BAY2395840
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
HCV
TMC435350-TiDP16-C109: A Safety Study for TMC435350 in an Oral Solution Containing Either 100, 200 or 400 mg Equivalent of TMC435350 or Placebo in Healthy Japanese Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of three different doses of TMC435350 compared to placebo in healthy Japanese males.
- Trial name
- NCT00752544
- Testing
- TMC435350
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Asthma, Chronic Obstructive Pulmonary Disease
PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians
The purpose of conducting this study is to obtain PK data of Beclometasone Dipropionate (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium Bromide (GB) after inhalation of CHF 5993 in…
- Trial name
- NCT03859414
- Testing
- Therapeutic Dose 1, Therapeutic Dose 2, Supra-therapeutic Dose
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use
Food and Insulin Effect on QT/QTC Interval of ECG
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or…
- Conditions
- Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State
- Trial name
- C11035 (NCT01642485)
- Testing
- Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Richmond Pharmacology Limited