Absorption and Tolerability Studies of an Emulsion Containing the Coconut Oil-derived Glycerol Tridecanoate in Healthy Men

NCT03255889 | Withdrawn Phase 1 DMC

• 1 other identifier: GT2016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to test safety and tolerance of oral intake of GT oil in the form of a non-diary based emulsion (10g of GT per emulsion) in healthy men. This will be a single center study, and the recruitment is expected to happen over a 1-2- month's period.

Conditions

Polycystic Ovary Syndrome

Keywords

Safety; Tolerability; Pharmacokinetics; Absorption

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events/severe events

  Incidence and severity of adverse events/serious adverse events based on history, physical examination and vital signs and clinical chemistry

  8 to 10 days

Secondary Outcomes (1)

• Decanoic acid

  3 months

Study Arms (2)

Active

ACTIVE COMPARATOR

Glyceryl Tridecanoate emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts

Drug: Glyceryl Tridecanoate

Placebo

PLACEBO COMPARATOR

Sunflower oil emulsion, single doses (5 g, 10 g, 20 g) to 3 cohorts

Other: Placebo

Interventions

Glyceryl Tridecanoate DRUG

Glyceryl Tridecanoate (GT) is the triglyceride form of decanoic acid (DA), a C10 fatty acid. GT belongs to the class of medium chain triglycerides (MCT), which has been accepted as a Generally Recognized As Safe food product by FDA. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%).

Also known as: GT

Active

Placebo OTHER

Sunflower oil emulsion of equal calories.

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men
• years of age
• Healthy as determined by medical, physical examination and clinical laboratory results
• Weigh at least 60 kg.
• Reliable and willing to follow study procedures.
• Able to read/ understand English
• Given written informed consent approved by NUS and the Ethical Review Board governing the site.

You may not qualify if:

• Known allergies to coconut oil, or related compounds,
• History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data.
• History of drug abuse
• Evidence of hepatitis B infection
• Given a blood donation of more than 450 mL in the last 3 months or any blood donation within the last month.
• Intend to use over-the counter or prescription medication known to affect reproductive or metabolic functions (e.g. hormonal pills, metformin and etc.) including steroidal preparations or intend to use vitamin, mineral, herbal or dietary supplements or intend to consume GT health supplements during the study
• Participants will be advised to avoid consuming coconut oil, or palm oil or any food products/ health supplements containing any of these oils during the study and 3 days prior to the study.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Investigational Medicine Unit, National University Health System

Singapore, 117599, Singapore

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Eu Leong Yong, MD & PhD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2017
• First Posted: August 21, 2017
• Study Start: August 28, 2017
• Primary Completion: September 24, 2017
• Study Completion: March 28, 2018
• Last Updated: December 7, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)