Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects

NCT00893971 | Completed Phase 1 Results

• 1 other identifier: PT0030901
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (16)

• Symptoms of Dry Mouth

  Number of participants reporting dry mouth at 12 hours post-dose

  12 hours

• Symptoms of Tremor

  Number of participants reporting tremor at 12 hours post-dose

  12 hours

• Blood Chemistry Change From Baseline

  Series of 11 blood chemistries assessed throughout the study

  24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

• Hematology Change From Baseline

  Hematology assessments taken throughout the study Hematocrit

  24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

• Hematology Change From Baseline

  Hematology assessments taken throughout the study

  24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

• Hematology Change From Baseline

  Hematology assessments taken throughout the study Hemoglobin

  24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

• Heart Rate Change From Baseline

  Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)

  12 hours

• Vital Sign Change Baseline; Blood Pressure

  Vital sign change baseline; blood pressure

  12 hours

• Vital Sign Change From Baseline, SpO2

  Vital Sign Change from baseline 12-hours post-dose SpO2 (%)

  12 hours

• ECG Change From Baseline

  Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)

  12 hours

• ECG Change From Baseline

  Change from baseline for ECG parameters 12-hours post-dose

  12 hours

• Spirometry Change From Baseline

  Change from baseline for spirometery measures 12-hours post-dose

  12 hours

• Spirometry Change From Baseline

  Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)

  12 hours

• Spirometry Change From Baseline

  Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)

  12 hours

• Spirometry Change From Baseline

  Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)

  12 hours

• Serum Potassium Change From Baseline

  12 hours

Secondary Outcomes (12)

• Plasma Glycopyrrolate PK Parameters

  Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

• Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)

  Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

• Plasma Glycopyrrolate PK Parameters (Tmax)

  Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

• Plasma Glycopyrrolate PK Parameters (t1/2)

  Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

• Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)

  Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose

Study Arms (4)

1

EXPERIMENTAL

Inhaled PT001 18 μg

Drug: PT001

2

EXPERIMENTAL

Inhaled PT005 2.4 μg

Drug: PT005

3

EXPERIMENTAL

Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)

Drug: PT003

4

EXPERIMENTAL

PT001 18 μg + PT005 2.4 μg

Drug: PT001 + PT005

Interventions

PT001 DRUG

Inhaled PT001, single dose

1

PT005 DRUG

Inhaled PT005, single dose

2

PT003 DRUG

Inhaled PT003, single dose

3

PT001 + PT005 DRUG

Inhaled PT001 + PT005, single dose

4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide signed written informed consent
• years of age
• Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and clinical laboratory tests
• Female subjects of child-bearing potential who are sexually active must be willing to undergo a pregnancy test and agree to use two forms of contraception
• Body mass index (BMI) between 18.5 and 30, inclusive
• Non-smokers for at least 6 months prior to screening
• Pulmonary function tests within normal limits
• Willing to remain at the study center for at least 12-24 hours on each test day
• Venous access in both arms to allow collection of numerous blood samples

You may not qualify if:

• Women who are pregnant or lactating
• Clinically significant medical conditions
• Viral illness within the last 30 days
• Symptomatic prostatic hypertrophy or bladder neck obstruction
• Known narrow-angle glaucoma
• History of bowel obstruction
• Clinically significant abnormal electrocardiogram
• Positive Hepatitis B surface antigen or positive Hepatitis C antibody
• Positive screening test for HIV antibodies
• History of hypersensitivity to any beta2-agonists, anticholinergics, or any component of the MDI
• Known or suspected history of alcohol or drug abuse within the last 2-years
• Greater than normal alcohol consumption
• Ingestion of any poppy seeds within the 48 hours prior to the screening
• Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines or grapefruit-containing foods or beverages within the 24 hours prior to, or during, each confinement
• Positive breath alcohol result

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

Dr Joanne Marjason

Herston, Queensland, 4006, Australia

Location

Results Point of Contact

• Title: Colin Reisner, MD, FCCP, FAAAAI
• Organization: Pearl Therapeutics Inc.

creisner@pearltherapeutics.com

605-305-2600

Study Officials

• Colin Reisner, M.D.

  Pearl Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: May 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-03

Locations

AU (1)