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Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects

P

Pearl Therapeutics

Status and phase

Completed
Phase 1

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: PT010 (BGF MDI) 320/14.4/9.6 µg
Drug: PT003 (GFF MDI) 14.4/9.6 µg
Drug: PT010 (BGF MDI) 160/14.4/9.6 µg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03075267
PT010010

Details and patient eligibility

About

A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects

Full description

A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects Following a Single Administration and After Chronic Administration for 7 Days

Enrollment

96 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male and female Chinese subjects 18-45 years of age
  • Females of childbearing potential must agree to be abstinent or else use one of the medically acceptable forms of contraception A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception.

A male subject with female partner of child bearing potential must agree to use one additional form of medically acceptable contraception

-Be in good general health as assessed at Screening and have no clinically significant abnormal labs at Screening.

Exclusion criteria

  • Pregnant or nursing female subjects or subjects who are trying to conceive
  • Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
  • Subjects with a history of ECG abnormalities
  • Subjects who have cancer that has not been in complete remission for at least 5 years
  • Male subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator
  • Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
  • Males with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
  • Subjects with a diagnosis of glaucoma that in the opinion of the Investigator has not been adequately treated
  • History of substance-related disorders within 1 year of Screening
  • History of smoking or the use of nicotine containing products or electronic cigarettes within 3 months of Screening by self-reporting
  • A positive alcohol breathalyzer or urine drug screen for drugs of abuse at the Screening Visit or at the beginning of each inpatient period
  • Treatment with any prescription or non-prescription drugs (including vitamins, herbal, and dietary supplements) within 30 days
  • Positivity for human immunodeficiency virus (HIV) or Hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at Screening
  • Positive for Syphilis Antibody
  • Subjects with any flu-like syndrome or other respiratory infections
  • Recently vaccinated with an attenuated live virus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 3 patient groups

PT010 (BGF MDI) 320/14.4/9.6 µg
Experimental group
Description:
PT010 Budesonide, Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler (BGF MDI) 320/14.4/9.6 µg
Treatment:
Drug: PT010 (BGF MDI) 320/14.4/9.6 µg
PT010 (BGF MDI) 160/14.4/9.6 µg
Experimental group
Description:
PT010 (BGF MDI) 160/14.4/9.6 µg
Treatment:
Drug: PT010 (BGF MDI) 160/14.4/9.6 µg
PT003 (GFF MDI) 14.4/9.6 µg
Experimental group
Description:
PT003 (GFF MDI) 14.4/9.6 µg
Treatment:
Drug: PT003 (GFF MDI) 14.4/9.6 µg

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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