Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606 (NCT04041648) | Clinical Trial Compass
CompletedPhase 1
Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606
United States52 participantsStarted 2018-11-09
Plain-language summary
The primary objective of this study is to evaluate the Pharmacokinetics, Safety and Tolerability of L606 (Liposomal Treprostinil) Inhalation Solution in Single Ascending Dose study design in healthy volunteers.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Males or females, of any race, 18 to 50 years of age, inclusive, at Screening.
✓. Body mass index between 18.5 and 32.0 kg/m2, inclusive, at Screening.
✓. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is not acceptable) at Screening or Check in as assessed by the Investigator (or designee).
✓. Ability of the subject to generate spirometry according to minimum ATS/ERS guidance criteria.
✓. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Section 6.6.
✓. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
✓. Agree to abstain from consuming alcohol from 72 hours prior to Check-in.
✓. Agree to refrain from strenuous exercise from 7 days prior to Check-in.
Exclusion criteria
✕. Clinically relevant abnormalities identified during Screening, physical examination, 12 lead ECG, or laboratory examinations.
✕. Clinically significant history of hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, and/or musculoskeletal disease, glaucoma, psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
What they're measuring
1
The number of treatment-emergent adverse events for L606 and placebo, including abnormal laboratory events
✕. History of anaphylaxis, significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless deemed not clinically significant by the Investigator (or designee).
✕. History of postural hypotension, unexplained syncope, or hypertension.
✕. History of asthma, chronic obstructive pulmonary disease (COPD), or reactive airways conditions or findings consistent with asthma or COPD on spirometry testing.
✕. Blood pressure \<90 mmHg systolic or \<50 mmHg diastolic after supine for 5 minutes at Screening or Check in upon repeat testing.
✕. Blood pressure \>150 mmHg systolic or \>90 mmHg diastolic after supine for 5 minutes at Screening or Check in upon repeat testing.
✕. Pulse rate \>100 bpm after supine for 5 minutes at Screening or Check-in upon repeat testing.