general health general health
Conditions
Interventions
Deodorant met gelabeled aluminum en intraveneuze toediening van gelabeled
aluminum
Sponsors
TNO
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 including vital signs, 12-lead ECG, haematology, blood chemistry, 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, frequent defined as at least three times a week); 6. 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 obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety; 2. A positive pregnancy test and/or nursing at screening; 3. 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; 4. Treatment for diabetes, hypertension, coronary heart disease, psychiatric conditions, inflammatory chronic disease - rheumatoid arthritis, Crohn*s disease, ulcerous colitis, chronic constipation, eating disorders, or any disease condition which interferes with ADME of the investigational product 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. Reported menopausal state at screening, or posthysterectomy; 6. Known allergy for aluminium; 7. Axillary hyperhydrosis; 8. 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; 9. Participation in an investigational drug study within 3 months prior to screening or more than 4 times in the past year; 10. 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; 11. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week); 12. Donation of blood within 3 months prior to screening or donation of plasma within 14 days prior to screening; 13. Not having a general practitioner; 14. 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; 15. Not willing to give permission to have the general practitioner to be notified upon participation in this study; 16. Not willing to use effective (double barrier) contraception until at least 3 months after last investigational product administration; 17. Subjects who are part of the site staff of TNO or CHDR.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability / safety endpoints Assessment of adverse events and local tolerability. Pharmacokinetic endpoints Assessment of the pharmacokinetics (PK) after topical application of 26AI, as [26Al]-ACH, and IV administration of 26AI, as [26Al]-AlCl3 in citrate-buffered physiological NaCl solution. | — |
Countries
Netherlands
Outcome results
None listed