Clinical trial NCT02196714: PK Study of PT003 and PT001 in Japanese Healthy Subjects
Official title: A Phase I, Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001 in Japanese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Keywords: Japanese Healthy Volunteers
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-Blind, Single-Dose, Four-Period, Four-Treatment, Cross-Over, Single-Center, Phase I, Crossover Study in Healthy Japanese Adult Subjects to Evaluate the Safety and Pharmacokinetics of Two Doses of PT003 and Two Doses of PT001.


Eligibility criteria: Inclusion Criteria:

Informed Consent Form (ICF) prior to any study related procedures

* Male and female first generation Japanese subjects 18 to 45 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

Primary outcomes:
measure: Cmax
timeFrame: Day 1
measure: Cmax
timeFrame: Day 1
measure: AUC 0-12
timeFrame: Day 1
measure: AUC 0-12
timeFrame: Day 1
measure: AUC 0-t
timeFrame: Day 1
measure: AUC 0-t
timeFrame: Day 1
measure: AUC 0-∞
timeFrame: Day 1
measure: AUC 0-∞
timeFrame: Day 1
measure: Tmax
timeFrame: Day 1
measure: Tmax
timeFrame: Day 1
measure: T 1/2
timeFrame: Day 1
measure: T 1/2
timeFrame: Day 1
measure: CL/F
timeFrame: Day 1
measure: CL/F
timeFrame: Day 1
measure: Vd/F
timeFrame: Day 1
measure: Vd/F
timeFrame: Day 1
measure: Lambda z
timeFrame: Day 1
measure: Lambda z
timeFrame: Day 1
Secondary outcomes:
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 Hours
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 Hours
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 Hours
measure: Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 Hours
measure: Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 hours
measure: Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 hours
measure: Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 hours
measure: Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose
timeFrame: 12 hours
measure: Change in Heart Rate From Pre-dose to 12 Hours Post Dose
timeFrame: 12 hours
measure: Change in PR Interval From Pre-dose to 12 Hours Post Dose
timeFrame: 12 hours
measure: Change in QRS Axis From Pre-dose to 12 Hours Post Dose
timeFrame: 12 hours
measure: Change in QRS Duration From Pre-dose to 12 Hours Post Dose
timeFrame: 12 hours
measure: Change in QT Interval From Pre-dose to 12 Hours Post Dose
timeFrame: 12 hours
measure: Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose
timeFrame: 12 hours
measure: Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose
timeFrame: 12 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL
state: Maryland
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Chadwick Orevillo
role: STUDY_CHAIR
References:
citation: Reisner C, Miller J, DePetrillo P, Maes A, Siddiqui S, Martin UJ. Pharmacokinetics and safety of a single dose of the novel LAMA/LABA fixed-dose combination of glycopyrronium/formoterol fumarate dihydrate metered dose inhaler, formulated using co-suspension delivery technology, in Japanese healthy subjects. Pulm Pharmacol Ther. 2018 Dec;53:33-38. doi: 10.1016/j.pupt.2018.09.005. Epub 2018 Sep 13.