A phase 1, randomized, double-blind, placebo-controlled, single-site study to assess the safety, tolerability, pharmacokinetics and food effect of MIN-102 following oral administration of single and multiple ascending doses in healthy male volunteers

A phase 1, randomized, double-blind, placebo-controlled, single-site study to assess the safety, tolerability, pharmacokinetics and food effect of MIN-102 following oral administration of single and multiple ascending doses in healthy male volunteers - MIN-102 SAD/FE/MAD Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42947

Enrollment

Registered

2016-05-17

Start date

2016-06-08

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metabolic disorder X-linked adrenoleukodystrophy

Interventions

Part A: The study will consist of 4 periods during which the volunteer will receive MIN-102 or placebo once in each period. MIN-102 and placebo will be given as oral suspension of 20 mL. Part B: T

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male volunteers 18 - 55 yrs, inclusive BMI: 18.0 - 28.0 kg/m2, inclusive non-smoking

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in a drug study within 90 days prior to the first drug administration in the current study. Participation in more than 3 other drug studies (for male subjects) in the 10 months prior to (the first) drug administration in the current study. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for male subjects) in the 10 months prior to (the first) drug administration in the current study.

Design outcomes

Primary

Measure	Time frame
Part A: To evaluate the safety and tolerability of MIN-102 administered orally as a single dose in healthy male volunteers. Part B: To evaluate the safety and tolerability of MIN-102 administered orally as a multiple dose in healthy male volunteers. Part C: To evaluate the safety and tolerability of MIN-102 administered orally as a multiple dose in healthy male volunteers.	—

Secondary

Measure	Time frame
Part A: - To evaluate the PK parameters in plasma and urine of MIN-102 and M3 after a single oral administration of MIN-102 in healthy male volunteers. - To evaluate the food effect (FE) in the PK of MIN-102 and M3 after a single oral administration of MIN-102 in healthy male volunteers. - To evaluate the enantiomer proportionality of MIN-102 in plasma. - To evaluate the adiponectin and fatty acid binding protein 4 (FABP4) levels in plasma before and after a single dose of MIN-102 Part B: - To evaluate the PK parameters in plasma and CSF of MIN-102 and M3 after single and multiple oral administrations of MIN-102 in healthy male volunteers. - To evaluate the levels in plasma and CSF of biomarkers (adiponectin, FABP4, cytokines [interleukin 6 (IL-6), interleukin 1 receptor agonist (IL-1ra), interleukin-8 (IL-8)] chemokines [monocyte chemotactic protein 1 (MCP-1), C-X-C motif chemokine 10-Interferon gamma-induced protein 10 (CXCL10IP10)], and adhesion molecules [soluble intercellular adhesion molecules (sICAM) and soluble vascular cellular adhesion molecule-1 (sVCAM1)]) after multiple oral administrations of MIN-102. Part C: - To evaluate the PK parameters in plasma and cerebrospinal fluid (CSF) of MIN-102 and M3 after single and multiple oral administrations of MIN-102 in healthy male volunteers. - To evaluate the levels of biomarkers (adiponectin, FABP4, CRP, cytokines [IL-6, IL- 1ra, IL-8] chemokines [MCP-1, CXCL10IP10], and adhesion molecules [sICAM and sVCAM1]) in plasma and CSF after multiple oral administrations of MIN-102.	—

Measure

Time frame

Part A: - To evaluate the PK parameters in plasma and urine of MIN-102 and M3 after a single oral administration of MIN-102 in healthy male volunteers. - To evaluate the food effect (FE) in the PK of MIN-102 and M3 after a single oral administration of MIN-102 in healthy male volunteers. - To evaluate the enantiomer proportionality of MIN-102 in plasma. - To evaluate the adiponectin and fatty acid binding protein 4 (FABP4) levels in plasma before and after a single dose of MIN-102 Part B: - To evaluate the PK parameters in plasma and CSF of MIN-102 and M3 after single and multiple oral administrations of MIN-102 in healthy male volunteers. - To evaluate the levels in plasma and CSF of biomarkers (adiponectin, FABP4, cytokines [interleukin 6 (IL-6), interleukin 1 receptor agonist (IL-1ra), interleukin-8 (IL-8)] chemokines [monocyte chemotactic protein 1 (MCP-1), C-X-C motif chemokine 10-Interferon gamma-induced protein 10 (CXCL10*IP10)], and adhesion molecules [soluble intercellular adhesion molecules (sICAM) and soluble vascular cellular adhesion molecule-1 (sVCAM1)]) after multiple oral administrations of MIN-102. Part C: - To evaluate the PK parameters in plasma and cerebrospinal fluid (CSF) of MIN-102 and M3 after single and multiple oral administrations of MIN-102 in healthy male volunteers. - To evaluate the levels of biomarkers (adiponectin, FABP4, CRP, cytokines [IL-6, IL- 1ra, IL-8] chemokines [MCP-1, CXCL10*IP10], and adhesion molecules [sICAM and sVCAM1]) in plasma and CSF after multiple oral administrations of MIN-102.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)