NCT02355756

Development of a Target Engagement Biomarker for Future PAC1 Antagonists With the Use of Intradermal Injected Maxadilan Induced Dermal Blood Flow Changes, Assessed by Laser Doppler Imaging

Completed EARLY_PHASE1 Last updated 9 July 2015

What this trial tests

EARLY_PHASE1 trial testing Maxadilan in Healthy Volunteers in 20 participants. Completed in 1 April 2015.

Timeline

1 January 2015

Primary endpoint
1 April 2015

1 April 2015

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 January 2015
Primary completion	1 April 2015
Estimated completion	1 April 2015
Sites	1 location across Belgium

Drugs / interventions tested

• Maxadilan — full drug profile →
• Placebo

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

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

• Change in dermal blood flow induced by intradermal injections of maxadilan, compared to baseline and placebo for different doses, time point and in terms of reproducibility over time (i.e. inter-period reproducibility).
  Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II)
• Changes in vital signs.
  Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at 5-7 days after last studyvisit (post-study visit)
  as a measure of safety
• Changes in ECG.
  Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
  as a measure of safety
• Change in laboratory safety tests.
  Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
  as a measure of safety
• Change in physical examination.
  Time frame: Every studyvisit (Day 1, 8 and 15 for part I/Day 1 and 8 for part II) and at at 5-7 days after last studyvisit (post-study visit)
  as a measure of safety

Sponsor's own description

This will be a single center, open-label study in healthy male subjects between 18 and 45 years old to determine the dose response profiles of dermal blood flow in response to intradermal injections of maxadilan. The study will consist of 2 parts: Part I: dose and time finding and Part II: reproducibility over time.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.