Randomized, Crossover Safety and Pharmacokinetics Study of PT010

NCT02197975 | Completed Phase 1

• 1 other identifier: PT010003-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• The pharmacokinetic profile of PT010

  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.

  12 hours

Secondary Outcomes (1)

• Overall safety of PT010

  12 hours

Study Arms (3)

PT010 Dose 1

EXPERIMENTAL

PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.

Drug: PT010 Dose 1

PT010 Dose 2

EXPERIMENTAL

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

Drug: PT010 Dose 2

Placebo MDI

PLACEBO COMPARATOR

Placebo MDI. Administered as 2 inhalations

Drug: Placebo MDI

Interventions

PT010 Dose 1 DRUG

PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.

PT010 Dose 1

PT010 Dose 2 DRUG

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

PT010 Dose 2

Placebo MDI DRUG

Placebo MDI. Administered as 2 inhalations

Placebo MDI

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Huang Y, Assam PN, Feng C, Su R, Dorinsky P, Gillen M. Ethnic pharmacokinetic comparison of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) between Asian and Western healthy subjects. Pulm Pharmacol Ther. 2020 Oct;64:101976. doi: 10.1016/j.pupt.2020.101976. Epub 2020 Nov 2.

  PMID: 33152467 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chadwick Orevillo

  Pearl Therapeutics

  STUDY CHAIR

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: July 21, 2014
• First Posted: July 23, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

US (1)