PharmacokineticsPhase 1NCT05452785
A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects
A Phase 1 study testing DFD-29 (Minocycline) Fasting, DFD-29 (Minocycline) Fed and Solodyn (Minocycline) Fasting in people with Pharmacokinetics, run by Journey Medical Corporation at 1 site in Canada.
Trial summary
Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- DFD-29 (Minocycline) Fasting, DFD-29 (Minocycline) Fed and Solodyn (Minocycline) Fasting
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2022to 25 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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
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- 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),
- (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:
- 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.
Who cannot join
- 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).
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- 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.
- 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
- Use of St. John's wort in the 28 days prior to the first study treatment administration
- 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
- Any history of tuberculosis
- Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first study treatment administration
- Positive Screening results to HIV Ag/Ab combo, hepatitis B surface antigen, or hepatitis C virus tests
- Inclusion in a previous group for this clinical study
- Intake of minocycline in the 28 days prior to the first study treatment administration
- Intake of an IP in the 28 days prior to the first study treatment administration
- Donation of 50 mL or more of blood in the 28 days prior to the first study treatment administration
- Donation of 500 mL or more of blood in the 56 days prior to the first study treatment administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Dose, Three-Way Crossover Comparative Bioavailability Study of DFD-29 (Minocycline Hydrochloride ER Capsules 40 mg) Versus SOLODYN® (Minocycline Hydrochloride ER Tablets 105 mg), Under Fasting and Fed Conditions in Healthy Adult Human Subjects
Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.
Read the detailed description
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-hour overnight fast Treatment-B: A single 40 mg dose of DFD-29 (Minocycline Hydrochloride) (1 × 40 mg Extended-Release capsule) administered following a 10-hour overnight fast and 30 minutes after the start of a high-fat, high calorie breakfast Treatment-C: A single 105 mg dose of SOLODYN® (Minocycline Hydrochloride) (1 × 105 mg Extended-Release tablet) administered following a 10-hour overnight fast.
Number of Subjects: Twenty-four (24) subjects will be included in the study Duration of the Study: Up to 58 days (including Screening) - Single dose treatment in each period.
PK Sample Collection: In each study period, 20 blood samples will be collected for PK assessments. The first blood sample will be collected prior to study treatment administration while the other blood samples will be collected at different timepoints up to 72 hours after study treatment administration.
- Conditions
- Pharmacokinetics
- Being tested
- DFD-29 (Minocycline) Fasting, DFD-29 (Minocycline) Fed, Solodyn (Minocycline) Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFD-29 (Minocycline) FastingDrug
Also called Minocycline Hydrochloride
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.
DFD-29 (Minocycline) FedDrug
Also called Minocycline Hydrochloride
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.
Solodyn (Minocycline) FastingDrug
Also called Minocycline Hydrochloride
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Drug: Solodyn (Minocycline) Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time '0' to '72' hours after a single dose treatment
Secondary outcomes (1)
Number of participants with treatment-related adverse events (AE)
Assessment and comparison between treatments of the number of participants with adverse events (AE).
Measured: Before and up to 14 days after the last dose study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start7 May 2022
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Journey Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Responsible party
- Sponsor
- Investigators
- Srinivas R Sidgiddi, M.D., Study director, Journey Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452785
- Sponsor's protocol ID
- DFD-29-CD-003
- Status last verified
- Feb 2023
- First submitted
- 19 Jun 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Dose, Three-Way Crossover Comparative Bioavailability Study of DFD-29 (Minocycline Hydrochloride ER Capsules 40 mg) Versus SOLODYN® (Minocycline Hydrochloride ER Tablets 105 mg), Under Fasting and Fed Conditions in Healthy Adult Human Subjects
- ClinicalTrials.gov ID
- NCT05452785
- Acronym / sponsor ID
- DFD-29-CD-003
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Journey Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Dr. Reddy's Laboratories Limited
- Study start
- 7 May 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single-center, randomized, open-label, laboratory-blinded, 3-treatment, 3-period, 6-sequence, single-dose, crossover study.
Detailed description
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-hour overnight fast Treatment-B: A single 40 mg dose of DFD-29 (Minocycline Hydrochloride) (1 × 40 mg Extended-Release capsule) administered following a 10-hour overnight fast and 30 minutes after the start of a high-fat, high calorie breakfast Treatment-C: A single 105 mg dose of SOLODYN® (Minocycline Hydrochloride) (1 × 105 mg Extended-Release tablet) administered following a 10-hour overnight fast.
Number of Subjects: Twenty-four (24) subjects will be included in the study Duration of the Study: Up to 58 days (including Screening) - Single dose treatment in each period.
PK Sample Collection: In each study period, 20 blood samples will be collected for PK assessments. The first blood sample will be collected prior to study treatment administration while the other blood samples will be collected at different timepoints up to 72 hours after study treatment administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| DFD-29 under fasting condition | Experimental | Drug: DFD-29 (Minocycline) FastingIn 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. |
| DFD-29 after high-fat meal | Experimental | Drug: DFD-29 (Minocycline) FedIn 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. |
| Solodyn under fasting condition | Active comparator | Drug: Solodyn (Minocycline) FastingIn 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Physiological postmenopausal status, defined as the following:
- Surgical postmenopausal status, defined as the following:
- 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:
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFD-29 (Minocycline) FastingAlso: Minocycline HydrochlorideIn 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 under fasting condition |
| DFD-29 (Minocycline) FedAlso: Minocycline HydrochlorideIn 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 after high-fat meal |
| Solodyn (Minocycline) FastingAlso: Minocycline HydrochlorideIn 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 under fasting condition |
Primary outcome
Peak Plasma Concentration (Cmax) of DFD-29 compared to Solodyn(R)
Time frame: Time '0' to '72' hours after a single dose treatment
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.
Area under the Curve (AUC0-inf) of DFD-29 compared to Solodyn(R)
Time frame: Time '0' to '72' hours after a single dose treatment
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.
1 secondary outcome
Number of participants with treatment-related adverse events (AE)
Time frame: Before and up to 14 days after the last dose study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinivas R Sidgiddi, M.D. study director
Journey Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DFD-29 (Minocycline) Fasting, DFD-29 (Minocycline) Fed and Solodyn (Minocycline) Fasting in people with Pharmacokinetics, run by Journey Medical Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) of DFD-29 compared to Solodyn(R) (time frame: Time '0' to '72' hours after a single dose treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.