Phase 1
N=42
Malaria: Relative Bioavailability and Food Effect of DSM265
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT03637517 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Cmax — 15300; 14200; 11200 NG/ML — p=0.4847
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- DSM265-TPGS 34% SDD, 400 mg fasted (Drug); DSM265-TPGS 34% SDD, 400 mg fed (Drug); DSM265 25% SDD, 400 mg fasted (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medicines for Malaria Venture
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
15300; 14200; 11200 | 0.4847 |
| PRIMARY AUC168 |
1100000; 987000; 1160000 | 0.1135 |
| PRIMARY AUCt |
1750000; 1570000; 1840000 | 0.1759 |
| PRIMARY Tmax |
2.4; 2.1; 11.4 | — |
| PRIMARY β |
0.00556; 0.00531; 0.00595 | — |
| PRIMARY C168 |
4090; 3540; 4200 | 0.1745 |
| SECONDARY AUCinf |
1960000; 1760000; 2040000 | 0.3100 |
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.
Eligibility Criteria
- 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.
- Male or female between 18 and 55 years of age inclusive at the time of screening.
- 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.
- 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).
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- No history of any clinically significant sensitivity or allergy to any medication or food.
- No history of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or
Data sourced from ClinicalTrials.gov (NCT03637517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.