Healthy VolunteersPhase 1NCT02750384
Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects
A Phase 1 study testing DSM265 50% SDD granules and DSM265 25% SDD powder for suspension in people with Healthy Volunteers and Bioavailability, run by Medicines for Malaria Venture at 1 site in United States.
Trial summary
This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects 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, Bioavailability
- What is being tested?
- DSM265 50% SDD granules and DSM265 25% SDD powder for suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Jul 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects of non-child bearing potential:
- surgically sterile (by hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy or bilateral tubal ligation) OR
- postmenopausal (without use of hormonal contraceptive and spontaneous amenorrhea for 12 months and follicle stimulating hormone > 40 IU/mL age appropriate for menopause and no other medical explanation for amenorrhea)
- Males:
- If he (including those who have had a vasectomy) is sexually active with female partner(s) of childbearing potential, he must agree, from Day 1 through 120 days after the dose of study drug to practice the continuous acceptable methods of contraception with his partner(s).
- If he has a female partner who is postmenopausal or permanently sterile, the male subject must agree to use condoms from Day 1 through 120 days after the dose of study drug
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- Females must have negative pregnancy tests:
- at Screening within 28 days prior to initial study drug administration, and
- prior to dosing on Study Day -1
- Body Mass Index at least 18.0 and less than / equal to 29.9. Body weight must be >50 kg
- General good health, based on medical history, physical examination, vital signs, laboratory profile and Electrocardiogram
- Voluntarily sign and date each informed consent, approved by an Institutional Review Board, prior to any screening or study procedures
Who cannot join
- Female who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 60 days after the dose of study drug
- Male who is considering fathering a child or donating sperm during the study or for 120 days after the last dose of study drug
- History of significant sensitivity to any drug
- History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
- History of gastric surgery (except phyloromoyotomy for pyloric stenosis during infancy), vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
- Requirement for any over-the-counter or prescription medication, vitamins or herbal supplements, except contraceptives or hormone replacement therapy for females, on a regular basis
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- Use of any medication, vitamins / herbal supplements except contraceptives or hormone replacement therapy for females, within 2 weeks prior to study drug administration or within 5 half-lives, whichever is longer
- Receipt of any drug by injection within 30 days or 5 half-lives, whichever is longer, prior to study drug administration, except parenteral hormonal contraceptives for females
- Receipt of any investigational product within 6 weeks prior to study drug administration or 5 half-lives, whichever is longer
- Recent (6-month) history of drug or alcohol abuse
- Consumption of alcohol within 72 hours prior to study drug administration
- Consumption of grapefruit or grapefruit products, Seville oranges, starfruit, or products containing any of these ingredients, and/or quinine/tonic water from 7 days prior to study drug administration
- Use of tobacco or nicotine-containing products within 6 months before study drug administration
- Positive for hepatitis A virus immunoglobulin M, hepatitis B surface antigen or hepatitis C virus antibody or HIV antibodies. Negative HIV status will be confirmed at Screening and results will be maintained confidentially
- Positive screen for drugs of abuse, or alcohol or cotinine or positive and clinically significant urine adulterants test
- Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product in 8 weeks prior to study drug administration
- Current enrollment in another clinical study
- Previous enrollment in this study
- Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive DSM265
Trial locations and contacts
1 site in 1 country.
United States1 site
AbbVie Clinical Pharmacology Research Unit (ACPRU)
Grayslake, Illinois, IL 60030
About this study
Official title: An Assessment of the Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects
This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects
Read the detailed description
This is a randomized, open label, single dose, parallel group study consisting of 3 groups of 14 subjects each. Subjects will be confined for 3 days followed by outpatient assessments until Day 21. Blood samples for assessment of DSM265 plasma concentrations will be collected for 480 hours after dosing.
This study will compare the relative bioavailability of the oral DSM265 50% spray dried dispersion (SDD) granules with that of a reference 25% SDD powder for suspension formulation, and evaluate the effect of food on the DSM265 50% SDD granules
- Conditions
- Healthy Volunteers, Bioavailability
- Being tested
- DSM265 50% SDD granules, DSM265 25% SDD powder for suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSM265 50% SDD granulesDrug
Single oral dose 400 mg
DSM265 25% SDD powder for suspensionDrug
Single oral dose 400 mg
| Study group | Role | What they receive |
|---|---|---|
| 50% SDD granules, fasting | Experimental | 50% spray dried dispersion granules, fasting Receives: Drug: DSM265 50% SDD granules |
| 25% SDD powder for suspension, fasting | Active comparator | 25% spray dried dispersion powder for suspension, fasting Receives: Drug: DSM265 25% SDD powder for suspension |
| 50% SDD granules, fed | Experimental | 50% spray dried dispersion granules, fed Receives: Drug: DSM265 50% SDD granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSM265 maximum observed plasma concentration (Cmax)
Measured: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 time to Cmax (Tmax)
Measured: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 observed concentration at 168 hours after dosing (C168)
Measured: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 apparent terminal phase elimination rate constant (β)
Measured: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 terminal elimination half-life (t1/2)
Measured: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUCt)
Measured: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 area under the plasma concentration-time curve from time 0 to infinity (AUC∞)
Measured: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
Secondary outcomes (1)
safety evaluations
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: Pre-dose and Days 1, 2, 4, 6, 8, 10, 14, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Sponsor strategic decision based on preliminary results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
- Investigators
- David, Carter, MD, Principal investigator, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750384
- Sponsor's protocol ID
- B16-963
- Other IDs
- MMV_DSM265_16_01
- Status last verified
- Sep 2016
- First submitted
- 21 Apr 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02750384
- Acronym / sponsor ID
- B16-963
- Conditions
- Healthy Volunteers, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor strategic decision based on preliminary results
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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.
This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects
Detailed description
This is a randomized, open label, single dose, parallel group study consisting of 3 groups of 14 subjects each. Subjects will be confined for 3 days followed by outpatient assessments until Day 21. Blood samples for assessment of DSM265 plasma concentrations will be collected for 480 hours after dosing.
This study will compare the relative bioavailability of the oral DSM265 50% spray dried dispersion (SDD) granules with that of a reference 25% SDD powder for suspension formulation, and evaluate the effect of food on the DSM265 50% SDD granules
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50% SDD granules, fasting | Experimental | Drug: DSM265 50% SDD granules50% spray dried dispersion granules, fasting |
| 25% SDD powder for suspension, fasting | Active comparator | Drug: DSM265 25% SDD powder for suspension25% spray dried dispersion powder for suspension, fasting |
| 50% SDD granules, fed | Experimental | Drug: DSM265 50% SDD granules50% spray dried dispersion granules, fed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female subjects of non-child bearing potential:
- Males:
- Females must have negative pregnancy tests:
- Body Mass Index at least 18.0 and less than / equal to 29.9. Body weight must be >50 kg
- General good health, based on medical history, physical examination, vital signs, laboratory profile and Electrocardiogram
Key exclusion criteria (19 listed)
- Female who is pregnant, breastfeeding or is considering becoming pregnant during the study or for approximately 60 days after the dose of study drug
- Male who is considering fathering a child or donating sperm during the study or for 120 days after the last dose of study drug
- History of significant sensitivity to any drug
- History of epilepsy, any clinically significant cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness
- History of gastric surgery (except phyloromoyotomy for pyloric stenosis during infancy), vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
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 |
|---|---|---|
| DSM265 50% SDD granulesSingle oral dose 400 mg | Drug | 50% SDD granules, fasting, 50% SDD granules, fed |
| DSM265 25% SDD powder for suspensionSingle oral dose 400 mg | Drug | 25% SDD powder for suspension, fasting |
Primary outcome
DSM265 maximum observed plasma concentration (Cmax)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 time to Cmax (Tmax)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 observed concentration at 168 hours after dosing (C168)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 apparent terminal phase elimination rate constant (β)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 terminal elimination half-life (t1/2)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUCt)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
DSM265 area under the plasma concentration-time curve from time 0 to infinity (AUC∞)
Time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours
1 secondary outcome
safety evaluations
Time frame: Pre-dose and Days 1, 2, 4, 6, 8, 10, 14, and 21
Results and safety
The study was stopped early (reason given: Sponsor strategic decision based on preliminary results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- 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.
David, Carter, MD principal investigator
AbbVie
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 DSM265 50% SDD granules and DSM265 25% SDD powder for suspension in people with Healthy Volunteers and Bioavailability, 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?
The sponsor lists 12 inclusion and 19 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: stopped early, as of the sponsor's last update on 14 Sep 2016. 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?
The study was stopped early (reason given: Sponsor strategic decision based on preliminary results). Results are not available in the source record.
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?
DSM265 maximum observed plasma concentration (Cmax) (time frame: Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours). The study lists 7 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 14 Sep 2016.