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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03173625
• Other study ID #: AC-076-102
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2016
• Est. completion date: April 15, 2017

Study information

• Verified date: July 2018
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 15, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AC-076 for s.c. administration
Lyophilized AC-076A to be reconstituted with 1 mL of water for injection
• Placebo
Sterile 0.9% w/v sodium chloride solution

Locations

Country	Name	City	State
United States	Biotrial Inc.	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Treatment-emergent AEs and treatment-emergent serious AEs	From study treatment administration up to day 3
Primary	Changes from baseline in electrocardiogram (ECG) variables	ECG variables are to be recorded at rest using a standard 12-lead ECG	From study treatment administration up to day 3
Primary	Changes from baseline in supine blood pressure	Supine blood pressure (mmHg)	From study treatment administration up to day 3
Primary	Changes from baseline in pulse rate	Pulse rate (bpm)	From study treatment administration up to day 3
Secondary	Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays	Maximum (MPA) and final (FPA) platelet aggregation using light transmission aggregometry (LTA) assay.; % inhibition of platelet aggregation (IPA), MPA and FPA.; P2Y12 reaction units (PRU) using the VerifyNow P2Y12 assay.; IPA PRU	From baseline up to day 3
Secondary	Maximum plasma concentration (Cmax) of AC-076	Cmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile	From baseline up to day 3
Secondary	time to reach Cmax (tmax)	tmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile	From baseline up to day 3
Secondary	terminal half-life (t1/2)	t1/2 of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile	From baseline up to day 3
Secondary	Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of	AUC(0-t) of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile	From baseline up to day 3
Secondary	Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]	AUC(0-inf) of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile	From baseline up to day 3