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

NCT05452785 | Completed Phase 1 FDA Drug

• 1 other identifier: DFD-29-CD-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax) of DFD-29 compared to Solodyn(R)

  Peak plasma concentration (Cmax) - the 90% CI for the ratio of Geometric Least Square Means for the ln-transformed parameter Cmax will be compared between the three treatments.

  Time '0' to '72' hours after a single dose treatment

• Area under the Curve (AUC0-inf) of DFD-29 compared to Solodyn(R)

  Area under the Curve (AUC0-inf) - the 90% CI for the ratio of Geometric Least Square Means for the ln-transformed parameter AUC0-inf will be compared between the three treatments.

  Time '0' to '72' hours after a single dose treatment

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events (AE)

  Before and up to 14 days after the last dose study treatment

Study Arms (3)

DFD-29 under fasting condition

EXPERIMENTAL

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.

Drug: DFD-29 (Minocycline) Fasting

DFD-29 after high-fat meal

EXPERIMENTAL

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.

Drug: DFD-29 (Minocycline) Fed

Solodyn under fasting condition

ACTIVE COMPARATOR

In each study period, a single 105 mg dose of SOLODYN® Tablets will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast

Drug: Solodyn (Minocycline) Fasting

Interventions

DFD-29 (Minocycline) Fasting DRUG

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.

Also known as: Minocycline Hydrochloride

DFD-29 under fasting condition

DFD-29 (Minocycline) Fed DRUG

In each study period, a single 40 mg dose of DFD-29 Capsules will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.

Also known as: Minocycline Hydrochloride

DFD-29 after high-fat meal

Solodyn (Minocycline) Fasting DRUG

In each study period, a single 105 mg dose of SOLODYN® Tablets will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast.

Also known as: Minocycline Hydrochloride

Solodyn under fasting condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• Physiological postmenopausal status, defined as the following:
• Absence of menses for at least 1 year prior to the first study treatment administration (without an alternative medical condition); and
• Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; Or
• Surgical postmenopausal status, defined as the following:
• Bilateral oophorectomy; and
• Absence of menses for at least 90 days prior to the first study treatment administration; and
• The FSH levels ≥ 40 mIU/mL at Screening; Or
• 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),
• 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
• 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.

You may not qualify if:

• Female who is lactating
• Female who is pregnant according to the pregnancy test at Screening
• 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
• 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
• History of or current complaints of orthostatic hypotension, auto-immune disease or photosensitivity reactions to drugs.
• History or current complaints suggestive of raised intracranial pressure or vestibular disorders (e.g., light headedness, vertigo, and tinnitus).
• History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease
• Subject has liver enzymes i.e., alanine aminotransferase (ALT) and aspartate transaminase (AST) \> 1.5 x × upper limit of normal, at Screening.
• Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m2 at Screening
• 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
• Immunization with a Coronavirus Disease 2019 (COVID-19) vaccine in the 14 days prior to the first study treatment administration
• 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
• History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency, or glucose-galactose malabsorption
• 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)
• Any clinically significant illness in the 28 days prior to the first study treatment administration.

Sponsors & Collaborators

• Journey Medical Corporation: lead
• Dr. Reddy's Laboratories Limited: collaborator

Study Sites (1)

CRO

Québec, Canada

Location

MeSH Terms

Interventions

Minocycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Srinivas R Sidgiddi, M.D.

  Journey Medical Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Laboratory personnel conducting the PK sample assessments are blinded to the treatments.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study. Eligible subjects will be randomized to a treatment sequence as follows: ABC; BCA; CAB; ACB; BAC; CBA.

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: July 11, 2022
• Study Start: May 7, 2022
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)