Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02094521 | Evaluation of Optimal Dosing Conditions for GLP-1 Analogue NNC0113-0987 When Administered Orally in Healthy Male Subjects | PHASE1 | COMPLETED | 122 | — | — | Mar 1, 2014 | Jul 1, 2014 | Jan 29, 2015 | 1 | United Kingdom |
| NCT01978613 | Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects | PHASE1 | COMPLETED | 100 | — | — | Nov 1, 2013 | Jun 1, 2014 | Jun 30, 2014 | 1 | Germany |
| NCT01967589 | Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects | PHASE1 | COMPLETED | 82 | — | — | Oct 1, 2013 | May 1, 2014 | Jun 20, 2014 | 1 | United Kingdom |
| NCT01690169 | Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects | PHASE1 | COMPLETED | 45 | — | — | Sep 14, 2012 | Dec 11, 2012 | Feb 28, 2017 | 1 | United Kingdom |
| NCT01405261 | Trial Investigating the Safety of NNC 0113-0987 in Healthy Male Subjects | PHASE1 | COMPLETED | 101 | — | — | Aug 1, 2011 | May 1, 2012 | Nov 28, 2013 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| NNC0113-0987 | EXPERIMENTAL | - |
| Oral B (DC) | EXPERIMENTAL | Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing) |
| Oral D | EXPERIMENTAL | Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral C | EXPERIMENTAL | Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral B | EXPERIMENTAL | Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| Oral A | EXPERIMENTAL | Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing) |
| DC (dosing condition) | EXPERIMENTAL | Escalation design. |
| Placebo | PLACEBO_COMPARATOR | - |
| NNC 0113-0987 (gastro) | EXPERIMENTAL | - |
| NNC 0113-987 (coated) | EXPERIMENTAL | - |
| NNC 0113-987 (i.v) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NNC0113-0987 | DRUG | For oral administration. All subjects will be treated for 10 consecutive days with five days on 5 mg NNC0113-0987 followed by five days on 10 mg NNC0113-0987. Dose escalation is chosen to increase gastrointestinal tolerability. |
| placebo | DRUG | Tablets for one-daily oral administration. |
| oral NNC 0113-0987 | DRUG | Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation. |
| I.v. NNC 0113-0987 | DRUG | Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised. |
| oral placebo | DRUG | Subjects will be randomised to receive a single dose of placebo. |
Inclusion Criteria: * Male aged 18 between 55 years (both inclusive) at the time of signing informed consent * Good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judge...