A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453

Healthy Clinical Trial

Official title:

A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453, After Multiple Topical Applications in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052687
• Other study ID #: CLFX453X2101
• Secondary ID: 2013-002344-84
• Status: Completed
• Phase: Phase 1
• First received: January 15, 2014
• Last updated: May 14, 2015
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this first-in human study is to demonstrate systemic and local tolerability and investigate pharmacokinetics of LFX453 after multiple topical applications in healthy subjects.

The current study has been designed with three distinct parts. Part 1 focuses on safety and tolerability of once daily application on the back, prior to moving forward and assessing the safety and tolerability in more sensitive treatment areas in Part 2 or twice daily application in Part 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects of non-childbearing potential, 18 to 65 years of age inclusive (at the time of the screening visit), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

• Male subjects must agree to total abstinence from male:female intercourse or agree to use a condom during drug dosing and for four weeks after dosing has stopped.

Exclusion Criteria:

• History of serious allergic reaction to any drug.

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.

• History of any atopic dermatitis (only within the last 2 years), autoimmune disease, psoriasis or erythema multiforme.

• Presence of skin disease (e.g. warts) or skin features on treatment areas that may affect local tolerability or the ability of the investigator to evaluate local tolerability.

• History of heart failure, left ventricular dysfunction or known family history or known presence of long QT syndrome.

• A history of clinically significant ECG abnormalities, or any of the following ECG abnormalities at screening or baseline:

• 2nd or 3rd degree AV-block

• PR > 200 msec

• QRS complex > 120 msec

• QTcF > 450 msec (males)

• QTcF > 460 msec (females)

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LFX453 H1
LFX453 high dose cream 1
• LFX453 L1
LFX453 low dose cream 1
• LFX453 H2
LFX453 high dose cream 2
• LFX453 L2
LFX453 low dose cream 2
• Imiquimod
Imiquimod cream
• Placebo 1
Placebo cream 1
• Placebo 2
Placebo cream 2

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Mid Glamorgan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General safety (number of subjects with adverse events)	Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.	14 days	Yes
Primary	Local skin tolerability (tolerability score)	Summarized statistics on 5-point scale tolerability scores over 14 days of treatment.	14 days	Yes
Secondary	All parts: Amount (ng/mL) of LFX453 in plasma	Evaluate systemic steady state pharmacokinetics in human after topical administration of LFX453.	14 days	No
Secondary	Part 1 and 2: LFX453 concentrations (ng/g) in the skin	LFX453 analyzed in skin.	Day 14 and between days 18-21	No
Secondary	All parts: LFX453 concentration (ng/mL) in urine	LFX453 analyzed in urine.	Day 14	No