PK Study of PT003 and PT001 in Japanese Healthy Subjects

Pearl Therapeutics

Status and phase: Completed; Phase 1

Conditions: COPD

Treatments: Drug: Glycopyrronium (GP) Dose 1; Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2; Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1; Drug: Glycopyrronium (GP) Dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02196714

PT003010-00

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups

Glycopyrronium and Formoterol Fumarate (GFF) Dose 1

Experimental group

Description:

Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)

Treatment:

Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 1

Glycopyrronium and Formoterol Fumarate (GFF) Dose 2

Experimental group

Description:

Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)

Treatment:

Drug: Glycopyrronium and Formoterol Fumarate (GFF) Dose 2

Glycopyrronium (GP) Dose 1

Experimental group

Description:

Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)

Treatment:

Drug: Glycopyrronium (GP) Dose 1

Glycopyrronium (GP) Dose 2

Experimental group

Description:

Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)

Treatment:

Drug: Glycopyrronium (GP) Dose 2