A Pharmacokinetic Study of Minocycline in Male and Female Volunteers
Information source: Foamix Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne
Intervention: FMX101, Minocycline 4% foam (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Foamix Ltd. Official(s) and/or principal investigator(s): Jacob Atsmon, MD, Principal Investigator, Affiliation: Sourasky Medical center, Tel-aviv, Israel
Overall contact: Jacob Atsmon, MD, Phone: +972 3 6974845, Email: jacoba@tlvmc.gov.il
Summary
The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101
4% foam product in male and female some of which are with acne
Clinical Details
Official title: An Open-label, Multiple Dose Study to Assess the Pharmacokinetic Profile of Minocycline From FMX-101 Foam (4%) in Male and Female Volunteers
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: adverse eventsirritation and local reaction Change from baseline in vital signs Cmax Tmax AUCT T½
Detailed description:
This is an open-label, single-center, non-randomized, multiple-administrations study in
males and females, some of which are with acne.
Twelve (12) subjects will be enrolled to receive a daily dose of topical FMX-101 minocycline
(4%) foam for sixteen consecutive days.
Each subject will undergo screening procedures within 21 days prior to dosing, to assess his
eligibility to participate in the study, including a dermatological assessment of the acne
severity and distribution (for subjects with acne).
On Days 1, 2, 3, 7, 9, 11, 14, 16 and 17 blood will be drawn for PK An End-of Study/Safety
Follow-up visit will take place on 7-10 days after last dose, which will also include a
dermatological assessment of response to treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Men and women between 18 and 35 years (inclusive) of age.
2. Clear skin or facial acne of any severity, currently untreated
3. Otherwise healthy subjects
4. Subjects who provide written informed consent to participate in the study.
5. Women of childbearing potential who are willing to use 2 reliable methods of
contraception or practice abstinence during the study period or be surgically
sterilized and agree to undergo repeated pregnancy tests.
6. Body Mass Index (BMI) 19. 0 to <30. 0 kg/m2 and weight ranging between 60-90 kg (males)
and 50-85 (females).
7. Non-smoking and no use of any tobacco or nicotine products (by declaration) for a
period of at least 6 months prior to screening visit
8. Subjects in general good health in the opinion of the investigator as determined by
medical history, vital signs, ECG and a physical examination.
9. Shaven facial hair (males)
10. Negative HIV, Hepatitis B and Hepatitis C serology tests at screening.
11. No clinically significant abnormalities in hematology, blood chemistry, or urinalysis
lab tests at screening.
12. No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse
determined within 21 days of the start of the study (screening visit).
13. Willingness to minimize exposure to sun for 20 days after first dosing
14. Subjects must be able to understand the requirements of the study and must be willing
to comply with the requirements of the study
Exclusion Criteria:
1. Documented history or ongoing symptoms of significant neurological, renal,
cardiovascular, respiratory (asthma), endocrinological, gastrointestinal,
hematopoietic disease, neoplasm or any other clinically significant medical disorder,
which in the investigator's judgment contraindicate administration of the study
medications.
2. Known or suspected pregnancy or lactation or planned pregnancy during the study
duration (females)
3. Use of topical antibiotics or topical corticosteroids for acne treatment within the
past 2 weeks.
4. Use of systemic corticosteroids within the past 4 weeks.
5. Use of systemic retinoids (e. g. isotretinoin) within the past 6 months.
6. Concurrent use of medications known to be photosensitizers because of the possibility
of augmented photosensitivity.
7. History or evidence of skin conditions other than acne (eg, eczema) that would
interfere with the subject's participation in the study.
8. Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or
dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for
symptomatic relief of pain is allowed until 24 hours prior to the study drug
administration.
9. Dermatological conditions which might have an effect upon dermal application, e. g.:
Psoriasis, mycosis fungoides, widespread acne, facial or back dermatophytosis, severe
hyperhydrosis, chronic or recurrent skin infections, ichtyosis
10. Excessive hair in the intended application areas
11. Current or recent (within 1year) drug or alcohol abuse.
12. Known contraindication, hypersensitivity and/or allergy to the study drug or its
excipients.
13. Subjects with significant allergic response to other drugs
14. Any acute illness (e. g. acute infection) within 48 hours prior to the first study
drug administration, which is considered of significance by the Principal
Investigator.
15. Participation in another clinical trial with drugs received within 3 months prior to
dosing (calculated from the previous study's last dosing date).
16. Subjects who donated blood in the three months or received blood or plasma
derivatives in the six months preceding study drug administration.
17. Subjects unable to communicate well with the investigators and CRC staff (i. e.,
language problem, poor mental development or impaired cerebral function).
18. Subjects who are non-cooperative or unwilling to sign consent form.
Locations and Contacts
Jacob Atsmon, MD, Phone: +972 3 6974845, Email: jacoba@tlvmc.gov.il
Sourasky Medical Center, Clinical Research Center, Tel-Aviv, Israel; Not yet recruiting Jacob Atsmon, MD Jacob Atsmon, MD, Principal Investigator
Additional Information
Starting date: September 2014
Last updated: September 24, 2014
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