Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects

Healthy Volunteers Clinical Trial

Official title:

An Assessment of the Bioavailability and Effect of Food on DSM265 Granules in Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02750384
• Other study ID #: B16-963
• Secondary ID: MMV_DSM265_16_01
• Status: Terminated
• Phase: Phase 1
• First received: April 21, 2016
• Last updated: September 13, 2016
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Medicines for Malaria Venture
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a single-dose, fasting and non-fasting, open-label, randomized, three-regimen, parallel group study in 42 subjects

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Bioavailability
• Healthy Volunteers

Intervention

Drug:
• DSM265 50% SDD granules
Single oral dose 400 mg
• DSM265 25% SDD powder for suspension
Single oral dose 400 mg

Locations

Country	Name	City	State
United States	AbbVie Clinical Pharmacology Research Unit (ACPRU)	Grayslake	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Medicines for Malaria Venture	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSM265 maximum observed plasma concentration (Cmax)		Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours	No
Primary	DSM265 time to Cmax (Tmax)		Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours	No
Primary	DSM265 observed concentration at 168 hours after dosing (C168)		Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours	No
Primary	DSM265 apparent terminal phase elimination rate constant (ß)		Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours	No
Primary	DSM265 terminal elimination half-life (t1/2)		Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours	No
Primary	DSM265 area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUCt)		Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours	No
Primary	DSM265 area under the plasma concentration-time curve from time 0 to infinity (AUC8)		Pre-dose and post-dose at 0.5, 1, 2, 4, 6, 8, 12, 24, 72, 120, 168, 216, 312 and 480 hours	No
Secondary	safety evaluations	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	Pre-dose and Days 1, 2, 4, 6, 8, 10, 14, and 21	Yes