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Randomized, Crossover Safety and Pharmacokinetics Study of PT010

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ClinicalTrials.gov Identifier: NCT02197975
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : October 28, 2014
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.

Condition or disease Intervention/treatment Phase
COPD Drug: PT010 Dose 1 Drug: PT010 Dose 2 Drug: Placebo MDI Phase 1

Detailed Description:
This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: PT010 Dose 1
PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
Drug: PT010 Dose 1
PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.

Experimental: PT010 Dose 2
PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
Drug: PT010 Dose 2
PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.

Placebo Comparator: Placebo MDI
Placebo MDI. Administered as 2 inhalations
Drug: Placebo MDI
Placebo MDI. Administered as 2 inhalations




Primary Outcome Measures :
  1. The pharmacokinetic profile of PT010 [ Time Frame: 12 hours ]

    The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on:

    • maximum plasma concentration (Cmax)
    • area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12)
    • area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t)
    • area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1)
    • time to maximum plasma concentration (tmax)
    • apparent terminal elimination half-life (t½)
    • apparent total body clearance (CL/F)
    • apparent volume of distribution (Vd/F)
    • terminal elimination rate constant (λz)
    • accumulation ratio for Cmax (RAC [Cmax])
    • accumulation ratio for AUC0 12 (RAC [AUC0 12]) Other PK parameters may be calculated, as appropriate.


Secondary Outcome Measures :
  1. Overall safety of PT010 [ Time Frame: 12 hours ]
    The safety associated with the use of PT010 will be assessed from physical examination findings, adverse event (AE) reporting, vital signs, clinical laboratory values, and findings from 12 lead electrocardiograms (ECGs).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed Consent Form (ICF) prior to any study related procedures
  • Male and female subjects first generation Japanese subjects 18 to 55 years, inclusive
  • Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5 and 32 kg/m2, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197975


Locations
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United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Chair: Chadwick Orevillo Pearl Therapeutics

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02197975     History of Changes
Other Study ID Numbers: PT010003-00
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Pearl Therapeutics, Inc.:
Healthy Volunteers
Additional relevant MeSH terms:
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Glycopyrrolate
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents