Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers

NCT03464864 | Completed Phase 1 FDA Drug

• 1 other identifier: MKC-475-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-related adverse events (safety and tolerability) of single ascending doses of Treprostinil Inhalation Powder

  Incidence and severity of treatment-related adverse events determined by changes from screening (baseline) of findings from physical examinations, laboratory evaluations, vital signs measurements, pulmonary testing, and ECG measurements.

  At protocol-specified time points from the time of screening (day 0) to end of study (day 6)

Secondary Outcomes (2)

• Systemic exposure and pharmacokinetics of treprostinil administered as Treprostinil Inhalation Powder in healthy normal volunteers

  At protocol-specified time points throughout day 1

• Dose proportionality

  10 months

Study Arms (8)

Treprostinil Inhalation Powder 30 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Treprostinil Inhalation Powder 60 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Treprostinil Inhalation Powder 90 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Treprostinil Inhalation Powder 120 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Treprostinil Inhalation Powder 150 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Treprostinil Inhalation Powder 180 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Treprostinil Inhalation Powder 240 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Treprostinil Inhalation Powder 300 mcg

EXPERIMENTAL

Drug: Treprostinil Inhalation Powder

Interventions

Treprostinil Inhalation Powder DRUG

Single ascending dose

Treprostinil Inhalation Powder 120 mcg; Treprostinil Inhalation Powder 150 mcg; Treprostinil Inhalation Powder 180 mcg; Treprostinil Inhalation Powder 240 mcg; Treprostinil Inhalation Powder 30 mcg; Treprostinil Inhalation Powder 300 mcg; Treprostinil Inhalation Powder 60 mcg; Treprostinil Inhalation Powder 90 mcg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily consents to participate in this study and provides written informed consent prior to the start of any study-specific procedures.
• Male or female. Females must not be pregnant or breastfeeding.
• Is between 18 and 55 years of age (inclusive).
• Female subjects must weigh between 55 and 100 kg, inclusive, with a body mass index (BMI) between 19.0-32.0 kg/m2, inclusive. Male subjects must weigh between 55 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive.
• Females must be of non-childbearing potential (defined as surgically sterile \[i.e. had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to the first dose of study medication\] or postmenopausal for at least 1 year prior to the first dose of study medication) or agree to use an acceptable form of birth control (see Section 4.4) from screening until 14 days after study completion.
• Medical history, physical examination, oropharyngeal examination, vital signs, ECG, spirometry, and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at screening.

You may not qualify if:

• History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
• A clinically significant abnormal finding on the physical exam, medical history, electrocardiogram (ECG), or clinical laboratory results at screening.
• History of chronic lung disease such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung disease, pulmonary fibrosis, etc.
• History of migraine headaches.
• History of a bleeding abnormalities (i.e., gingival bleeding, epistaxis, or blood on toilet paper, etc.) that is judged to be significant by the Investigator.
• Has forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio \< 80% predicted or FEV25-75 \<50% predicted.
• History of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
• Has been on a significantly abnormal diet (as determined by the Investigator) during the 4 weeks preceding the first dose of study medication.
• Has participated in another clinical trial (and received an investigational product) within 30 days prior to the first dose of study medication.
• Use of any over-the-counter (OTC) medication (including nutritional or dietary supplements, herbal preparations, or vitamins) within 7 days prior to the first dose of study medication until the end of study visit without evaluation and approval by the Medical Monitor.
• Use of any prescription medication, except hormonal contraceptive or hormonal replacement therapy, from 14 days prior to the first dose of study medication until the end-of-study visit without evaluation and approval by the Investigator.
• Has been treated with any known drugs that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes (e.g., barbiturates, phenothiazines, cimetidine, carbamazepine) within 30 days prior to the first dose of study medication, and that, in the Investigator's judgment, may impact subject safety or the validity of the study results.
• Blood or plasma donation within 30 days prior to the first dose of study medication.
• Smoking or use of tobacco- or nicotine-containing products within 6 months prior to the first dose of study medication until the end-of-study visit.
• Engagement in strenuous exercise within 48 hours prior to the first dose of study medication.

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

Investigational Site 441

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Senior Director, Clinical Pharmacology

  Mannkind Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 14, 2018
• Study Start: March 9, 2018
• Primary Completion: June 5, 2018
• Study Completion: June 5, 2018
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

US (1)