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Phase 1 N=42 Randomized Other

Malaria: Relative Bioavailability and Food Effect of DSM265

Healthy Volunteers

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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