General health General health
Conditions
Interventions
Topical application: Representative antiperspirant formulation containing ~2500
Bq/g 26Al (as 26Al-ACH) and ~20-25% ACH.
IV administration: Physiological saline solution, buffered with
acetate/citra
Sponsors
Cosmetics Europe The Personal Care Association A.I.S.B.L.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a physical examination (with emphasis on the axilla) including vital signs, 12-lead ECG, haematology, blood chemistry, virology and urinalysis; 2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive; 3. Able to communicate well with the investigator in the Dutch language; 4. Able to participate and willing to give written informed consent and to comply with the study restrictions; 5. Subjects should be used to frequent wet shaving with an appropriate female safety razor (electric shaving is not allowed, frequently is defined as at least three times a week); 6. Subjects should be used to frequent use of Al-containing product (frequently is defined as at least 5 times a week). 7. Sufficient venous access to allow blood sampling as per protocol.
Exclusion criteria
Exclusion criteria: 1. Any clinically significant abnormality as determined by medical history taking and physical examinations (e.g. scars, cuts, wounds, tattoos, and/or dermal abnormalities in the axilla) obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; 2. History of pathological scar formation (keloid, hypertrophic scars) 3. A positive pregnancy test and/or nursing at screening; 4. Use of aluminium-containing medications within 21 days prior to investigational product administrations, or less than 5 half-lives, whichever is longer, and during the course of the study; 5. Known allergy for aluminium; 6. Axillary hyperhydrosis (including subjects treated for this condition (e.g. with botox)); 7. Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; 8. Participation in an investigational drug study within 3 months prior to screening or more than 4 times in the past year; or participation in part A 9. Any psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol; 10. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week); 11. Donation of blood within 3 months prior to screening or donation of plasma within 14 days prior to screening; 12. Not having a general practitioner; 13. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner; 14. Not willing to give permission to have the general practitioner to be notified upon participation in this study; 15. Not willing to use effective (double barrier) contraception until at least 3 months after last investigational product administration; 16. Subjects who are part of the site staff of CHDR or TNO employees; 17. Having a tattoo applied within 3 months prior to, or during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints - Treatment-emergent (serious) adverse events ((S)AEs); - Local tolerability; - Clinical laboratory tests o Haematology o Chemistry o Urinalysis - Vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) Pharmacokinetic endpoints The following endpoints will be determined for 26Al as 26Al-ACH (topical application) or as 26Al-AlCl3 (IV administration). They will be derived by non-compartmental analysis of the blood concentration-time data: - The area under the blood concentration-time curve from zero to infinity(AUC0-inf); - The maximum blood concentration (Cmax); - The area under the blood concentration-time curve from zero to t of the last measured concentration above the limit of quantification (AUC0-last); - The time to reach maximum blood concentration (tmax); - The terminal disposition rate constant (*z) with the respective half-life (t*). - Other parameters, including Vz/F, CL/F, and other parameters as appropriate, as well as dose adjusted parameters, may be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic endpoints - 26Al content in urine and feces - 26Al content in the skin as determined in tape-strips and skin punch biopsies | — |
Countries
Netherlands
Outcome results
None listed