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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):
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT00925678
First received: June 19, 2009
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Dainippon Sumitomo Pharma:

Primary Outcome Measures:
  • Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical chemistry, haematology, urinalysis [ Designated as safety issue: No ]
  • Nasal symptoms and peak nasal inspiratory flow [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Biomarkers nasal lavage and blood [ Designated as safety issue: No ]

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
Genders 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
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
Dainippon Sumitomo Pharma
  More Information

No publications provided

Responsible Party: Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier: NCT00925678     History of Changes
Other Study ID Numbers: D7002013
Study First Received: June 19, 2009
Last Updated: June 11, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 16, 2013