A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects

Launched by JOURNEY MEDICAL CORPORATION · Jul 7, 2022

Keywords

ClinConnect Summary

Primary Objectives:

* To assess the comparative bioavailability of DFD-29 (Minocycline ER Capsules 40 mg) versus SOLODYN® (Minocycline ER Tablets 105 mg) following a single oral dose administration under fasting conditions in healthy adult human subjects.
* To assess the effect of food on DFD-29 (Minocycline ER Capsules 40 mg).

Secondary Objective:

- To evaluate and compare the safety and tolerability profiles of each study treatment.

Study Treatments:

Treatment-A: A single 40 mg dose of DFD-29 (Minocycline Hydrochloride) (1 × 40 mg Extended-Release capsule) administered following a 10...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Provision of signed and dated Informed Consent Form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy adult male or postmenopausal females 4. If female, meets one of the following criteria:
• 1. Physiological postmenopausal status, defined as the following:
• • 1. Absence of menses for at least 1 year prior to the first study treatment administration (without an alternative medical condition); and
• • 2. Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; Or
• 2. Surgical postmenopausal status, defined as the following:
• • 1. Bilateral oophorectomy; and
• • 2. Absence of menses for at least 90 days prior to the first study treatment administration; and
• • 3. The FSH levels ≥ 40 mIU/mL at Screening; Or
• • 3. Hysterectomy with FSH levels ≥ 40 mIU/mL at Screening If postmenopausal and has an FSH of \< 40 mIU/mL, but meets all other criteria in (1),
• (2), or (3) above as well as all the other inclusion criteria, Screening estradiol serum level must be equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, eligibility for study participation will be based on medical judgment. 5. If male, meets one of the following criteria:
• 1. Is able to procreate and agrees to use one of the accepted contraceptive regimens and not to donate sperm from the first study treatment administration to at least 90 days after the last study treatment administration. An acceptable method of contraception includes one of the following:
• • Abstinence from heterosexual intercourse
• • Male condom with spermicide or male condom with a vaginal spermicide (gel, foam, or suppository) Or
• • 2. Is unable to procreate; defined as surgically sterile (i.e., has undergone a vasectomy at least 180 days prior to the first study treatment administration) 6. Aged at least 18 years but not older than 65 years 7. Body mass index (BMI) within 18.5 kg/m2 to 29.9 kg/m2, inclusively 8. Body weight greater than 50 kg 9. Non- or ex-smoker (An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study treatment administration) 10. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an Investigator.
• Exclusion Criteria:
• • 1. Female who is lactating
• • 2. Female who is pregnant according to the pregnancy test at Screening
• • 3. History of significant hypersensitivity or idiosyncratic reaction to minocycline or any of the tetracyclines (eg. severe skin reactions, erythema multiforme and/or drug reaction with eosinophilia and systemic symptoms) or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• • 4. Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
• • 5. History of or current complaints of orthostatic hypotension, auto-immune disease or photosensitivity reactions to drugs.
• • 6. History or current complaints suggestive of raised intracranial pressure or vestibular disorders (e.g., light headedness, vertigo, and tinnitus).
• • 7. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
• • 8. Subject has liver enzymes i.e., alanine aminotransferase (ALT) and aspartate transaminase (AST) \> 1.5 x × upper limit of normal, at Screening.
• • 9. Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m2 at Screening
• • 10. Presence of out-of-range cardiac interval (PR \< 110 msec, PR \> 200 msec, QRS \< 60 msec, QRS \>110 msec and QTcF \> 440 msec) on the ECG at Screening or other clinically significant ECG abnormalities, unless deemed non-significant by an Investigator
• • 11. Immunization with a Coronavirus Disease 2019 (COVID-19) vaccine in the 14 days prior to the first study treatment administration
• • 12. Scheduled immunization with a COVID-19 vaccine during the study that, in the opinion of an Investigator, could potentially interfere with subject participation, subject safety, study results, or any other reason
• • 13. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency, or glucose-galactose malabsorption
• • 14. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• • 15. Any clinically significant illness in the 28 days prior to the first study treatment administration.
• • 16. Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study treatment administration, that in the opinion of an Investigator would put into question the status of the participant as healthy
• • 17. Use of St. John's wort in the 28 days prior to the first study treatment administration
• • 18. Use of any antacids containing aluminum, calcium or magnesium, iron-containing preparations, or bismuth preparations in the 7 days prior to the first study treatment administration
• • 19. Any history of tuberculosis
• • 20. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first study treatment administration
• • 21. Positive Screening results to HIV Ag/Ab combo, hepatitis B surface antigen, or hepatitis C virus tests
• • 22. Inclusion in a previous group for this clinical study
• • 23. Intake of minocycline in the 28 days prior to the first study treatment administration
• • 24. Intake of an IP in the 28 days prior to the first study treatment administration
• • 25. Donation of 50 mL or more of blood in the 28 days prior to the first study treatment administration
• • 26. Donation of 500 mL or more of blood in the 56 days prior to the first study treatment administration.