CUV038: Measurement of drug blood levels over time in healthy male volunteers

Completed

• Conditions: The drug is intended to treat patients with light exposure disorders (for example UV light).; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12611000784910
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Healthy adult males with Fitzpatrick skin types I, II or III aged between 18 and 45 years
(inclusive).
* Free of significant abnormal findings as determined during the screening procedure by surgical and medical history, physical examination, ECG, clinical laboratory testing and vital signs.
* BMI between 18 and 30 kg/m2.
* No history of drug abuse, licit or illicit (including alcohol).
* Agree not to use any medications (prescribed, over-the-counter or complementary medications) without pre-approval by the Principal Investigator during the 7 days preceding the study, and during the course of the study (until Day 90).
* Willing to take precautions to prevent pregnancy with their partner until completion of the study (Day 90) and 30 days thereafter.
* Able to understand and sign the written Informed Consent Form.
* Able and willing to follow the Protocol requirements, including refraining from the use of tanning products and excessive UV light exposure from the start of the study until Day 90

Exclusion Criteria

* Any personal history of melanoma or dysplastic nevus syndrome.
* Any significant history of allergy and/or sensitivity to any of the contents of study drug
product.
* Any significant history of allergy and/or sensitivity to lignocaine.
* Any significant illness during the 4 weeks before the study screening period.
* Any contraindication to blood sampling.
* Any factor that may interfere with the skin reflectance measurements (e.g. excessive moles, freckles or excessively hairy skin).
* Regularly drinks more than 4 standard drinks of alcohol per day (1 standard drink = 300 mL
beer, 1 glass wine, 1 measure spirit).
* Participation in any clinical study during the 6 weeks before the study screening period.
* Has donated 400 mL or more of blood or had significant blood loss during the 8 weeks
preceding screening.
* Has donated plasma within the 7 days preceding screening.
* Solarium use in the three months prior to study involvement and throughout the duration of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified