Clinical trial NCT03173625: A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body
Official title: Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of AC-076 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) of 18.0 to 31.0 kg/m2 (inclusive) at screening
* Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 45-90 beats per minute (inclusive) at screening
* Healthy on the basis of physical examination, electrocardiogram and laboratory tests
* Maximum (at peak) platelet aggregation ≥ 40%
* Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen/epinephrine and collagen/ADP below the upper limit of normal range at screening

Exclusion Criteria:

* Known hypersensitivity to AC-076 or drugs of the same class, or any of their excipients
* Family or personal history of prolonged bleeding or bleeding disorders, intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers
* Platelet count \< 120 × 109 L-1 at screening
* Known platelet disorders
* Orthostatic hypotension at screening (i.e., decrease from supine to standing BP of \> 20 mmHg in SBP or \> 10 mmHg in DBP after being in standing position for 3 min)
* Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs or any medication with blood thinning activity within 3 weeks prior to study drug administration; or with any other prescribed medications (including vaccines) or over the counter medications within 2 weeks prior to study drug administration
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: From study treatment administration up to day 3
measure: Changes from baseline in electrocardiogram (ECG) variables
timeFrame: From study treatment administration up to day 3
measure: Changes from baseline in supine blood pressure
timeFrame: From study treatment administration up to day 3
measure: Changes from baseline in pulse rate
timeFrame: From study treatment administration up to day 3
Secondary outcomes:
measure: Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays
timeFrame: From baseline up to day 3
measure: Maximum plasma concentration (Cmax) of AC-076
timeFrame: From baseline up to day 3
measure: time to reach Cmax (tmax)
timeFrame: From baseline up to day 3
measure: terminal half-life (t1/2)
timeFrame: From baseline up to day 3
measure: Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of
timeFrame: From baseline up to day 3
measure: Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]
timeFrame: From baseline up to day 3
Other outcomes:
Locations:
city: Newark
country: United States
facility: Biotrial Inc.
state: New Jersey
Study officials:
affiliation: Actelion
name: Pierre-Eric JUIF, PhD
role: STUDY_DIRECTOR
References: