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Healthy VolunteersPhase 1NCT03637517

Malaria: Relative Bioavailability and Food Effect of DSM265

A Phase 1 study testing DSM265-TPGS 34% SDD, 400 mg fasted, DSM265-TPGS 34% SDD, 400 mg fed and DSM265 25% SDD, 400 mg fasted in people with Healthy Volunteers, run by Medicines for Malaria Venture at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
DSM265-TPGS 34% SDD, 400 mg fasted, DSM265-TPGS 34% SDD, 400 mg fed and DSM265 25% SDD, 400 mg fasted
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
3 Oct 2018to 19 Nov 2018
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult
  1. Subjects or their legally authorized representative must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee(IEC) / Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
  2. Male or female between 18 and 55 years of age inclusive at the time of screening.
  3. Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
  4. Females must be of Non-Childbearing Potential as defined below Females do not need to use birth control during or following study drug treatment if considered of non-childbearing potential due to meeting any of the following criteria:
  • Postmenopausal, age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an follicle stimulating hormone (FSH) level > 40 IU/L.
  • Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  1. Female who is not pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 120 days after the last dose of study drug.
  2. Male subjects who are sexually active with a female partner of childbearing potential, must agree to use condoms, even if the male subject has undergone a successful vasectomy, from Study Day 1 through 120 days after the last dose of study drug. His female partner(s) must also use at least one of the following methods of birth control:
  • Combined (oestrogen and progestogen containing) hormonal birth control (oral, intravaginal, injectable, transdermal) associated with inhibition of ovulation initiated at least 30 days prior to study Baseline Day 1.
  • Progestogen-only hormonal birth control (oral, injectable, implantable) associated with inhibition of ovulation initiated at least 30 days prior to study Baseline Day 1.
  • Bilateral tubal occlusion/ligation.
  • Intrauterine device (IUD).
  • Intrauterine hormone-releasing system (IUS).
  1. Male who is not considering fathering a child or donating sperm during the study or for approximately 120 days after the last dose of study drug.
  2. Laboratory values meet the following criteria:
  • Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ the upper limit of normal (ULN) at the Screening Visit and upon initial confinement.
  • Negative test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody (Ab) and human immunodeficiency virus (HIV) at screening visit.
  • Negative screen for drugs of abuse, alcohol or cotinine at screening and upon initial confinement.
  • For non-postmenopausal female subjects, a negative urine pregnancy test at the screening visit and a negative serum pregnancy test upon initial confinement and prior to the first dose of study drug.
  • No other laboratory results that the investigator determines are clinically significant.
  • Platelets greater than or equal to the lower limit of normal.
  1. No clinically significant ECG abnormalities including
  • No evidence of 2nd or 3rd degree AV block at screening visit and upon initial confinement.
  • QT interval corrected for heart rate (QTc) using Fridericia's correction formula (QTcF) is ≤ 430 msec (males) or ≤ 450 msec (females) at screening visit and upon initial confinement.
  1. A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
  2. No history of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
  3. No history of any clinically significant sensitivity or allergy to any medication or food.
  4. No history of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection].
  5. No evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
  6. No history of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
  7. Has not donated blood (including plasmapheresis), lost ≥ 550 mL blood volume, or received a transfusion of any blood product within 8 weeks prior to study drug administration.
  8. No consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
  9. No use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
  10. No history of clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
  11. Is not currently enrolled in another interventional clinical study.
  12. Has not been previously enrolled in this study.
  13. In the opinion of the investigator, this subject is a suitable candidate for enrollment in the study.
  14. Subjects must not have been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug.
  15. Subject must not have received any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 weeks after the last dose of study drug.
  16. Subject must not require any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, on a regular basis.
  17. Subject must not use any medications within the 2-week period prior to study drug administration.
  18. Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
  19. No use of known inhibitors (e.g., ketoconazole) or inducers (e.g., carbamazepine) of cytochrome P450 3A (CYP3A) within 1 month prior to study drug administration.
  20. No exposure to DSM265 within the past 90 days prior to first dose of study drug.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AbbVie Clinical Pharmacology Research Unit (ACPRU)

    Grayslake, Illinois, 60030

Other trials in United States

About this study

Official title: Relative Bioavailability and Effect of Food on DSM265-TPGS 34% SDD Powder in Healthy Adult Subjects

Phase 1 study designed to evaluate the relative bioavailability of a single dose of a test formulation, DSM265-TPGS 34% SDD powder in comparison with a reference DSM265 25% SDD powder formulation used in early clinical trials.

Read the detailed description

The objective of this study is to compare the relative bioavailability of oral DSM265-TPGS 34% SDD formulation with that of a reference 25% SDD powder for suspension used in previous clinical trials. Another objective of the study is to evaluate the effect of food on bioavailability of the DSM265-TPGS 34% SDD formulation.

The current 25% SDD powder for suspension clinical formulation is a suspension which requires reconstitution/administration in 240 mL sucralose based vehicle (for a 400 mg adult dose). This volume is too large for paediatric patients with malaria (e.g., translates into a 30 mL volume for 0.5-2 yr old patients); also, the dosing vehicle is not commercially viable. The new formulation dissolves in a smaller volume of a more common vehicle, water (40 mL for 400 mg adult dose).

Being tested
DSM265-TPGS 34% SDD, 400 mg fasted, DSM265-TPGS 34% SDD, 400 mg fed, DSM265 25% SDD, 400 mg fasted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DSM265-TPGS 34% SDD, 400 mg fastedDrug

    Also called DSM265

    New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state.

  • DSM265-TPGS 34% SDD, 400 mg fedDrug

    Also called DSM265

    New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state.

  • DSM265 25% SDD, 400 mg fastedDrug

    Also called DSM265

    Reference formulation used in early clinical trials.

Study groups in NCT03637517
Study groupRoleWhat they receive
DSM265-TPGS 34% SDD, 400 mg fastedExperimentalSpray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)
Receives: Drug: DSM265-TPGS 34% SDD, 400 mg fasted
DSM265-TPGS 34% SDD, 400 mg fedActive comparatorSpray dried dispersion (SDD) formulation, powder containing 34.25% DSM265-TPGS (tocopheryl polyethylene glycol succinate)
Receives: Drug: DSM265-TPGS 34% SDD, 400 mg fed
DSM265 25% SDD, 400 mg fastedActive comparatorSpray dried dispersion (SDD) formulation, powder containing 25% DSM265 as free base
Receives: Drug: DSM265 25% SDD, 400 mg fasted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax

    Maximum observed DSM265 plasma concentration

    Measured: 21 days

  2. AUC168

    Area under the plasma concentration-time curve from time 0 to 168 hours (AUC168)

    Measured: 168 hours

  3. AUCt

    AUC from time 0 until the last measurable concentration (AUCt),

    Measured: 21 days

  4. Tmax

    Time to Cmax.

    Measured: 21 days

  5. β

    Apparent terminal phase elimination rate constant

    Measured: 21 days

  6. C168

    Plasma concentration at 168 hours

    Measured: 7 days

Secondary outcomes (1)

  1. AUCinf

    AUC from time 0 to infinity (AUCinf)

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2018
  2. Study start3 Oct 2018
  3. Primary completion19 Nov 2018
  4. Study completion19 Nov 2018

Resources

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
Parallel groups
Model description
Phase 1, single-dose, open-label, randomized, parallel group design in healthy adults (males, females of non child bearing potential) in 3 groups of 14 subjects each.
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03637517
Sponsor's protocol ID
MMV_DSM265_18_01
Other IDs
B19-227
Status last verified
Feb 2020
First submitted
15 Aug 2018
Last updated
11 Mar 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DSM265-TPGS 34% SDD, 400 mg fasted, DSM265-TPGS 34% SDD, 400 mg fed and DSM265 25% SDD, 400 mg fasted in people with Healthy Volunteers, run by Medicines for Malaria Venture at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 11 Mar 2020. 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 United States. 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?

Yes. Results are posted in the registry (first posted 11 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax (time frame: 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03637517.

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 11 Mar 2020.

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