Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

P

Pearl Therapeutics

Status and phase

Completed
Phase 1

Conditions

COPD

Treatments

Drug: PT009
Drug: Symbicort Turbohaler
Drug: PT010

Study type

Interventional

Funder types

Industry

Identifiers

NCT02189304
PT010002-00

Details and patient eligibility

About

This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.

Enrollment

59 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Informed Consent Form (ICF) prior to any study related procedures
  • Male and female subjects 18 to 55 years, inclusive
  • Good general health
  • Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
  • Clinical labs within normal ranges or determined to be not clinically significant by the Investigator

Exclusion criteria

  • Pregnancy, nursing female subjects, or subjects trying to conceive
  • Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
  • History of ECG abnormalities
  • Cancer not in complete remission for at least 5 years
  • Clinically significant, symptomatic prostatic hypertrophy
  • Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
  • Clinically significant bladder neck obstruction or urinary retention
  • Inadequately treated glaucoma
  • History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
  • Subjects with pre-existing anemia and/or iron deficiency

Trial design

59 participants in 3 patient groups

PT010
Experimental group
Description:
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Treatment:
Drug: Symbicort Turbohaler
Drug: PT009
PT009
Experimental group
Description:
PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Treatment:
Drug: PT010
Drug: Symbicort Turbohaler
Symbicort Turbohaler
Active Comparator group
Description:
Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
Treatment:
Drug: PT010
Drug: PT009

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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