NCT02029482

Single-center, Double-blind, Placebo-controlled, Randomized, Parallel-group, Up-titration Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Increasing Doses of ACT-128800 in Healthy Male and Female Subjects

Completed Phase 1 Last updated 6 January 2014

What this trial tests

Phase 1 trial testing ACT-128800 in Safety and Tolerability in 16 participants. Completed in 1 June 2010.

Timeline

1 April 2010

Primary endpoint
1 June 2010

1 June 2010

Quick facts

Lead sponsor	Actelion
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Enrollment	16
Start date	1 April 2010
Primary completion	1 June 2010
Estimated completion	1 June 2010
Sites	1 location across United Kingdom

Drugs / interventions tested

• ACT-128800 — full drug profile →
• Placebo

Conditions studied

• Safety and Tolerability — all drugs for Safety and Tolerability →

Sponsor

Actelion — full company profile →

Who can join

Adults 18 to 65, any sex, with Safety and Tolerability. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline to Day 18 in systolic blood pressure
  Time frame: 18 days
  Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
• Change from baseline to Day 18 in diastolic blood pressure
  Time frame: 18 days
  Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
• Change from baseline to Day 18 in pulse rate
  Time frame: 18 days
  Pulse rate was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
• Change from baseline to Day 18 in body temperature
  Time frame: 18 days
  Body temperature was measured in the supine position using the same thermometer throughout the study.

Sponsor's own description

This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1 study. Sixteen subjects in two groups (at least 40% of subjects of either male or female sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to 100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The S1P-S1PR Axis in Neurological Disorders-Insights into Current and Future Therapeutic Perspectives.
   Lucaciu A, Brunkhorst R, Pfeilschifter JM, Pfeilschifter W, et al · · 2020 · cited 53× · PMID 32580348 · DOI 10.3390/cells9061515