CClinicalTrials.gg
Sign In
CompletedNCT00692146Updated Jun 6, 2008

Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

A Phase 1 interventional study of AZD1386 and Placebo in Capsaicin Evoked Pain and Heat Sensitivity, sponsored by AstraZeneca. Completed. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-06.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study summary

A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers

02

Conditions studied

  • Capsaicin Evoked Pain
  • Heat Sensitivity

Browse trials for

Keywords

  • Proof of Mechanism
  • Capsaicin evoked pain
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 36 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
  • Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
  • Non-fertile females

Exclusion criteria

Exclusion Criteria:

  • History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
  • History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    1

    36 subjects receiving a specified volume of the active component AZD1386 in a single dose.

    Drug: AZD1386

  • Placebo comparator
    2

    36 subjects receiving a specified volume of placebo in a single dose.

    Drug: Placebo

Interventions

  • DrugAZD1386

    Oral solution fixed dose (95 mg given orally on two occasions)

  • DrugPlacebo

    Oral solution fixed dose (95 mg given orally on two occasions)

06

What researchers measure

Primary outcomes

  1. VAS, HPT

    Time frame: Visit 2-4

Secondary outcomes

  1. eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia

    Time frame: Visit 2-4

  2. Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3

    Time frame: Visit 1-5

  3. Pharmacokinetics/Pharmacodynamics

    Time frame: Visit 2-4

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00692146
Lead sponsor
AstraZeneca
First posted
Jun 6, 2008
Start date
Jan 2008
Primary completion
May 2008
Completion
May 2008
Last update
Jun 6, 2008

Study contacts

Agneta Berg
study chair · AstraZeneca R&D Södertälje
Ingemar Bylesjö
principal investigator · AstraZeneca R&D CPU Karolinska University Hospital, Stockholm

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypersensitivity→

Other studies from this sponsor

AstraZeneca

Start the discussion