A Safety, Tolerability and Pharmacokinetics Study of TransCon Treprostinil in Healthy Adult Male Volunteers

NCT03803163 | Terminated Phase 1

• 1 other identifier: TCP-PH-101
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the maximum tolerated dose (MTD) and assess safety and tolerability of escalating single doses of TransCon PEG treprostinil administered as a subcutaneous injection to healthy male volunteers.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Safety and tolerability of single doses of TransCon Treprostinil treatment

  42 days

Secondary Outcomes (1)

• Maximum Plasma Concentration [Cmax] of TransCon Treprostinil

  42 days

Study Arms (1)

TransCon Treprostinil

EXPERIMENTAL

Drug: TransCon Treprostinil

Interventions

TransCon Treprostinil DRUG

Also known as: ACP-009

TransCon Treprostinil

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject gives voluntary written informed consent to participate in the study.
• Subject is a healthy male between the ages of 18 and 50 years, inclusive, at Screening.
• Subjects must weigh between 60 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
• Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.
• Subject agrees to abstain from taking any prescription medication for 14 days prior to check-in and to abstain from taking any non-prescription medications (except multivitamins) or herbal supplements for 7 3 days prior to check-in Baseline until discharge from the study (unless prescribed by the Investigator to treat an AE).
• Subject agrees to abstain from consuming alcohol from three days prior to check-in and until discharge from the study.
• Subject agrees to refrain from strenuous exercise from check-in and until discharge from the study.
• Subject is able to communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements.

You may not qualify if:

• Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
• Subject has a history of anaphylaxis, a previous documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
• Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
• Subject has a history of postural hypotension, or unexplained syncope.
• Subject has a blood pressure that is less than 90 mmHg systolic or 50 mmHg diastolic at Screening or Baseline.
• Subject has a pulse rate that is greater than 90 bpm after sitting at rest for at least 5 minutes at Screening or Baseline.
• Subject has a history of hypertension.
• Subject has a blood pressure that is greater than 150 mmHg systolic or 90 mmHg diastolic at Screening or Baseline
• Subject has a predisposing condition that could interfere with the absorption, distribution, metabolism, or excretion of drugs.
• Subject has tested positive at the screening visit for HIV infection, HBsAg, or the HCV antibody.
• Subject currently uses tobacco or nicotine products or has a history of tobacco use within six months prior to Baseline.
• Subject has a history of alcohol abuse or a history of or current impairment of organ function reasonably related to alcohol abuse.
• Subject has a history of or current evidence of abuse of licit or illicit drugs, including a positive urine screen for drugs of abuse at Screening or Baseline.
• Subject has a history of abnormal bleeding tendencies.
• Subject has donated blood or plasma or has lost a significant volume of blood (greater than 450 mL) within four weeks prior to Baseline.

Sponsors & Collaborators

• Ascendis Pharma A/S: lead

Study Design

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

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 14, 2019

Record last verified: 2019-01