Randomized, Crossover Safety and Pharmacokinetics Study of PT010

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197975
• Other study ID #: PT010003-00
• Status: Completed
• Phase: Phase 1
• First received: July 21, 2014
• Last updated: October 27, 2014
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

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

Locations

Country	Name	City	State
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (AUC0-8) (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 (?z); accumulation ratio for Cmax (RAC [Cmax]); accumulation ratio for AUC0 12 (RAC [AUC0 12]) Other PK parameters may be calculated, as appropriate.	12 hours	No
Secondary	Overall safety of PT010	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).	12 hours	Yes