Recruitment

Recruitment Status
Completed
Estimated Enrollment
22

Inclusion Criteria

Subjects must have healthy skin on which reddening can easily be recognized (Fitzpatrick type I-IV skin);
Subjects must have a body mass index (BMI) of ≥18 kg/m2 and ≤32 kg/m2;
Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding.
...
Subjects must have healthy skin on which reddening can easily be recognized (Fitzpatrick type I-IV skin);
Subjects must have a body mass index (BMI) of ≥18 kg/m2 and ≤32 kg/m2;
Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding.
Male subjects must agree that they and any female partners will use 2 acceptable forms of contraception, 1 of which must be a condom, until 3 months after the last dose of study drug.
The planned application site must have unbroken skin (ie, free from cuts, scratches, and abrasions), and be free of excessive hair, tattoos, or other abnormality that, in the Investigator's judgement, would interfere with the conduct of the study;
Subjects must be adults (male or female), ages 18 to 65, inclusive;
Subjects must voluntarily give written informed consent and agree to comply with visit schedule including willingness to remain at the study site;

Exclusion Criteria

Men whose female partner is pregnant or lactating, or who plans to become pregnant during the study or within 3 months after the end of the study;
History of clinically significant drug allergies including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the Investigator;
Donation of whole blood >450 mL or blood products within 56 days prior to admission to the investigational site;
...
Men whose female partner is pregnant or lactating, or who plans to become pregnant during the study or within 3 months after the end of the study;
History of clinically significant drug allergies including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the Investigator;
Donation of whole blood >450 mL or blood products within 56 days prior to admission to the investigational site;
Positive breath test for alcohol at the Screening Visit or at Day -1;
Use of substances known to be strong inhibitors or inducers of Cytochrome P450 (CYP450) enzymes (eg, ritonavir, ketoconazole, nefazodone, grapefruit juice) within 14 days prior to the first dose of study drug through the last study visit. Chronic exposure to enzyme inducers such as paint solvents or pesticides or other investigational drug use within 30 days prior to study drug administration;
Use of any tobacco products, nicotine-containing products, or pharmacologic smoking cessation therapy during the 3 months immediately prior to the first dose of study drug, and/or not willing or able to refrain from use of any of these products for the duration of the study until after the last protocol specified blood sample;
Any abnormal clinical laboratory value or abnormal electrocardiogram (ECG) finding at the Screening Visit or at Day -1 that is considered clinically significant by the Investigator;
Use of prescription drugs, dietary supplements, or herbal remedies (including products applied topically) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug; use of non-prescription drugs or vitamins (including products applied topically) within 7 days prior to the first dose of study drug; or unwillingness to refrain from taking any such medication until after the last protocol specified blood sample;
Presence of active inflammatory dermatoses (eg, atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections;
Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines. History of appendectomy and cholecystectomy is permitted;
Acute illness accompanied by temperature ≥101○F within 5 days prior to study drug administration;
International Normalized Ratio (INR) >1.5 at the Screening Visit;
Use of any alcohol or methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, and "power drinks") from 72 hours prior to the first dose of study drug until after the last protocol specified blood sample;
History of alcohol abuse within 2 years of the Screening Visit, in the judgment of the Investigator, or average weekly alcohol consumption of >14 alcoholic drinks. One drink is defined as 1 glass of beer (approximately 10 oz to 12 oz) or 1 can (12 oz) of beer, 1 glass of wine (approximately 4 oz to 5 oz), or 1 glass of distilled spirits (hard liquor) containing 1 oz of the liquor (1 oz of liquid is approximately 30 mL);
Presence or history of cancer within 5 years prior to the Screening Visit (other than basal cell skin cancer in a location other than the back and without active lesions and adequately treated carcinoma in situ of cervix);
Not willing to abstain from strenuous exercise (eg, heavy lifting, weight training, calisthenics, aerobics) for at least 48 hours prior to admission to the investigational site until after the last protocol specified blood sample;
Persons with Fitzpatrick skin types V or VI;
Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at the Screening Visit;
Positive urine test for cotinine or drugs of abuse (ie, opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines) at the Screening Visit or at Day -1;
Use of any investigational drug within 30 days or 5 half-lives of the previous investigational drug prior to the first dose of study drug in this study, whichever is longer;
History of drug abuse within 2 years of the Screening Visit, in the judgment of the Investigator;
Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic disease

Summary

Conditions
Healthy
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Inclusion Criteria

Subjects must have healthy skin on which reddening can easily be recognized (Fitzpatrick type I-IV skin);
Subjects must have a body mass index (BMI) of ≥18 kg/m2 and ≤32 kg/m2;
Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding.
...
Subjects must have healthy skin on which reddening can easily be recognized (Fitzpatrick type I-IV skin);
Subjects must have a body mass index (BMI) of ≥18 kg/m2 and ≤32 kg/m2;
Women must be of non-childbearing potential and may not be pregnant, lactating, or breast-feeding.
Male subjects must agree that they and any female partners will use 2 acceptable forms of contraception, 1 of which must be a condom, until 3 months after the last dose of study drug.
The planned application site must have unbroken skin (ie, free from cuts, scratches, and abrasions), and be free of excessive hair, tattoos, or other abnormality that, in the Investigator's judgement, would interfere with the conduct of the study;
Subjects must be adults (male or female), ages 18 to 65, inclusive;
Subjects must voluntarily give written informed consent and agree to comply with visit schedule including willingness to remain at the study site;

Exclusion Criteria

Men whose female partner is pregnant or lactating, or who plans to become pregnant during the study or within 3 months after the end of the study;
History of clinically significant drug allergies including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the Investigator;
Donation of whole blood >450 mL or blood products within 56 days prior to admission to the investigational site;
...
Men whose female partner is pregnant or lactating, or who plans to become pregnant during the study or within 3 months after the end of the study;
History of clinically significant drug allergies including allergies to any of the components of the investigational product and/or clinically significant food allergies as determined by the Investigator;
Donation of whole blood >450 mL or blood products within 56 days prior to admission to the investigational site;
Positive breath test for alcohol at the Screening Visit or at Day -1;
Use of substances known to be strong inhibitors or inducers of Cytochrome P450 (CYP450) enzymes (eg, ritonavir, ketoconazole, nefazodone, grapefruit juice) within 14 days prior to the first dose of study drug through the last study visit. Chronic exposure to enzyme inducers such as paint solvents or pesticides or other investigational drug use within 30 days prior to study drug administration;
Use of any tobacco products, nicotine-containing products, or pharmacologic smoking cessation therapy during the 3 months immediately prior to the first dose of study drug, and/or not willing or able to refrain from use of any of these products for the duration of the study until after the last protocol specified blood sample;
Any abnormal clinical laboratory value or abnormal electrocardiogram (ECG) finding at the Screening Visit or at Day -1 that is considered clinically significant by the Investigator;
Use of prescription drugs, dietary supplements, or herbal remedies (including products applied topically) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug; use of non-prescription drugs or vitamins (including products applied topically) within 7 days prior to the first dose of study drug; or unwillingness to refrain from taking any such medication until after the last protocol specified blood sample;
Presence of active inflammatory dermatoses (eg, atopic dermatitis, psoriasis), bacterial, viral, or fungal skin infections;
Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines. History of appendectomy and cholecystectomy is permitted;
Acute illness accompanied by temperature ≥101○F within 5 days prior to study drug administration;
International Normalized Ratio (INR) >1.5 at the Screening Visit;
Use of any alcohol or methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, and "power drinks") from 72 hours prior to the first dose of study drug until after the last protocol specified blood sample;
History of alcohol abuse within 2 years of the Screening Visit, in the judgment of the Investigator, or average weekly alcohol consumption of >14 alcoholic drinks. One drink is defined as 1 glass of beer (approximately 10 oz to 12 oz) or 1 can (12 oz) of beer, 1 glass of wine (approximately 4 oz to 5 oz), or 1 glass of distilled spirits (hard liquor) containing 1 oz of the liquor (1 oz of liquid is approximately 30 mL);
Presence or history of cancer within 5 years prior to the Screening Visit (other than basal cell skin cancer in a location other than the back and without active lesions and adequately treated carcinoma in situ of cervix);
Not willing to abstain from strenuous exercise (eg, heavy lifting, weight training, calisthenics, aerobics) for at least 48 hours prior to admission to the investigational site until after the last protocol specified blood sample;
Persons with Fitzpatrick skin types V or VI;
Positive screen for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C at the Screening Visit;
Positive urine test for cotinine or drugs of abuse (ie, opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines) at the Screening Visit or at Day -1;
Use of any investigational drug within 30 days or 5 half-lives of the previous investigational drug prior to the first dose of study drug in this study, whichever is longer;
History of drug abuse within 2 years of the Screening Visit, in the judgment of the Investigator;
Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic disease

Tracking Information

NCT #
NCT02029716
Collaborators
AbbVie
Investigators
Not Provided
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