JPRN-jRCT2080222333
Unknown
Phase 1
Open-label study to assess safety, pharmacokinetics and exposed dose of NMK20 in healthy Japanese male subjects
ihon Medi-Physics Co., Ltd.0 sites6 target enrollmentDecember 19, 2013
ConditionsHealthy Japanese male subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Japanese male subjects
- Sponsor
- ihon Medi-Physics Co., Ltd.
- Enrollment
- 6
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body weight: 50\.0 kg or more
- •\-Body mass index: 18\.5 and more \- 25\.0 below
Exclusion Criteria
- •\-Subjects with abnormality found by liver function test or renal function test.
- •\-Subjects with a hypersensitive history to drugs or foods.
- •\-Subjects who have abused or are abusing drugs.
- •\-Subjects who were or are addicted to alcohol.
- •\-Subjects who have received an investigational new drug other than NMK20 from six months before screening up to hospital admission.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Open-label study to assess how the pharmacokinetics (i.e. the way the body absorbs, distributes and gets rid of a drug), safety, and tolerability of the drug siponimod are influenced by the presence of specific genetic characteristics (namely CYP2C9 genotypes).The medical condition pursued for siponimod is Secondary Progressive Multiple Sclerosis (SPMS). This study aims to characterize the PK profile of siponimod in healthy subjects with the CYP2C9 extensive and poor metabolizer phenotype.Neurological - Multiple sclerosisACTRN12613000545763ovartis Pharmaceuticals Australia Pty Limited24
Active, not recruiting
Not Applicable
An open label study on safety and pharmacokinetics of an intravenous administered single dose of Feramyl 200 mg in healthy blood donors compared to a single dose of Feramyl 1000 mg in IBD patients to evaluate dose dependency and kinetics after 1 hour infusion.EUCTR2013-001123-39-DKSerumWerk Bernburg AG16
Active, not recruiting
Phase 1
A study in people with cystic fibrosis who have a fungal lung infection, looking at the safety of inhaled PC945, it's effect on the body and how the body affects the drug.EUCTR2018-000243-87-GBPulmocide Ltd18
Active, not recruiting
Phase 1
Clinical Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric ParticipantsPediatric psoriasis(PsO)Juvenile psoriatic arthritis (jPsA)MedDRA version: 20.0Level: PTClassification code 10076674Term: Juvenile psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersTherapeutic area: Body processes [G] - Immune system processes [G12]EUCTR2021-005085-18-Outside-EU/EEAJanssen Research & Development, LLC
Completed
Phase 1
A study in healthy male volunteers to investigate how the test medicine is taken up, processed, and removed from the bodyPharmacokinetics, mass balance and metabolite profiles of NRD135S.E1 in healthy adult male volunteersNot ApplicableISRCTN51059297ovaremed AG (Switzerland)8