Randomized, Crossover Safety and Pharmacokinetics Study of PT010

Pearl Therapeutics

Status and phase: Completed; Phase 1

Conditions: COPD

Treatments: Drug: PT010 Dose 2; Drug: PT010 Dose 1; Drug: Placebo MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02197975

PT010003-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 3 patient groups, including a placebo group

PT010 Dose 1

Experimental group

Description:

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

Treatment:

Drug: PT010 Dose 1

PT010 Dose 2

Experimental group

Description:

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

Treatment:

Drug: PT010 Dose 2

Placebo MDI

Placebo Comparator group

Description:

Placebo MDI. Administered as 2 inhalations

Treatment:

Drug: Placebo MDI