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DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00925678
First received: June 19, 2009
Last updated: June 11, 2012
Last verified: June 2012
  Purpose
Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.

Condition Intervention Phase
Allergic Rhinitis
Healthy Volunteer
Drug: DSP-3025
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Official Title: A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

Resource links provided by NLM:


Further study details as provided by Sumitomo Dainippon Pharma Co., Ltd.:

Primary Outcome Measures:
  • Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry

Secondary Outcome Measures:
  • Clinical chemistry, haematology, urinalysis
  • Nasal symptoms and peak nasal inspiratory flow
  • Pharmacokinetics
  • Biomarkers nasal lavage and blood

Estimated Enrollment: 72
Study Start Date: June 2009
Arms Assigned Interventions
Experimental: 1 Drug: DSP-3025
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
  • No clinically relevant abnormal findings
  • History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)

Exclusion Criteria:

  • Acute illness which requires medical intervention
  • Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
  • Clinical relevant disease or disorder (past or present)
  • A history of asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925678

Locations
Japan
Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
  More Information

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT00925678     History of Changes
Other Study ID Numbers: D7002013
Study First Received: June 19, 2009
Last Updated: June 11, 2012

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2017